The FDA has granted final approval to Lantheus' Bravnetsa for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. Bravnetsa, or lutetium Lu 177 dotatate, has been determined by the FDA to be bioequivalent and therapeutically equivalent to Lutathera. The approval adds another radioligand therapy option for SSTR-positive GEP-NETs and introduces further competition in the US nuclear-medicine market. Field Content Alert Type Approval Drug Name Lutetium Lu 177 dotatate Brand Name Bravnetsa Company Lantheus Regulatory Authority U.S. Food and Drug Administration Approval Type Final approval Indication Adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours Therapy Area(s) Oncology; neuroendocrine tumours Technology or Modality Radioligand therapy Reference Product Lutathera Regulatory Status FDA determined Bravnetsa to be bioequivalent and therapeutically equivalent to Lutathera Geography United States What Happened The FDA granted final approval to Bravnetsa for adults with SSTR-positive GEP-NETs. Why It Matters The approval introduces an additional therapeutically equivalent lutetium Lu 177 dotatate product and expands competition in radioligand treatment. Supporting Context Lutetium Lu 177 dotatate delivers targeted radiation to tumour cells expressing somatostatin receptors. Key Takeaway Bravnetsa is now fully FDA approved as a therapeutic equivalent to Lutathera for SSTR-positive GEP-NETs. What to Watch Commercial launch, treatment-centre adoption and the effect of additional competition on radioligand therapy access. Primary Source Lantheus Relevant Date 22 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The FDA has approved Cordis' SELUTION SLR sirolimus drug-eluting balloon for treatment of coronary in-stent restenosis, making it the first sirolimus drug-eluting balloon available in the United States. The device delivers sustained sirolimus therapy to the vessel wall without leaving another permanent implant behind, providing a new interventional option for patients whose coronary stents have narrowed again. The approval expands the US coronary intervention toolkit and introduces a different drug-delivery approach for treating in-stent restenosis. Field Content Alert Type Approval Device Name SELUTION SLR Company Cordis Regulatory Authority U.S. Food and Drug Administration Approval Type Medical device approval Indication Treatment of coronary in-stent restenosis Therapy Area(s) Cardiology; interventional cardiology Technology or Modality Sirolimus drug-eluting balloon Geography United States What Happened The FDA approved Cordis' SELUTION SLR drug-eluting balloon for coronary in-stent restenosis. Why It Matters SELUTION SLR is the first sirolimus drug-eluting balloon approved in the US and provides drug delivery without implanting an additional permanent stent. Supporting Context In-stent restenosis occurs when treated coronary arteries narrow again after stent implantation and may require repeat intervention. Potential Impact The device could give interventional cardiologists another treatment option for restenosis while reducing the need for additional metal implants. Key Takeaway SELUTION SLR becomes the first FDA-approved sirolimus drug-eluting balloon for coronary in-stent restenosis in the US. What to Watch US commercial rollout, adoption in catheterisation laboratories and real-world outcomes compared with repeat stenting and other balloon technologies. Primary Source Cordis Relevant Date 21 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Grünenthal has agreed to acquire Bayer's established oncology medicine Stivarga in a transaction worth up to €375 million. The acquisition gives Grünenthal global rights to regorafenib, which is approved in more than 90 markets for indications including metastatic colorectal cancer, gastrointestinal stromal tumours and hepatocellular carcinoma. The transaction expands Grünenthal's portfolio of established medicines while allowing Bayer to transfer a mature oncology asset to a company focused on managing and commercialising established products. Field Content Alert Type Deal Companies Grünenthal; Bayer Deal Type Pharmaceutical asset acquisition Asset or Company Stivarga (regorafenib) Therapy Area(s) Oncology; colorectal cancer; gastrointestinal stromal tumours; hepatocellular carcinoma Technology or Modality Oral multikinase inhibitor Deal Value Up to €375 million Geography Global What Happened Grünenthal agreed to acquire Bayer's oncology medicine Stivarga and associated global rights for up to €375 million. Why It Matters The transaction transfers a globally established oncology medicine approved across multiple tumour types and significantly expands Grünenthal's mature-product portfolio. Supporting Context Stivarga is marketed in more than 90 countries and is used in metastatic colorectal cancer, gastrointestinal stromal tumours and hepatocellular carcinoma. Strategic Rationale Grünenthal gains a sizeable established oncology asset while Bayer streamlines its portfolio and transfers lifecycle management to a specialist in established medicines. Potential Impact The deal broadens Grünenthal's commercial footprint and adds a significant oncology revenue stream to its portfolio. Key Takeaway Grünenthal is acquiring Bayer's Stivarga franchise for up to €375 million. What to Watch Transaction completion, transfer of commercial operations and Grünenthal's strategy for lifecycle management of Stivarga. Primary Source Grünenthal Relevant Date 21 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The FDA has approved Aqneursa as the first treatment specifically indicated for ataxia in adults and children with ataxia-telangiectasia weighing at least 15kg. Aqneursa, or levacetylleucine, is approved to treat the neurological manifestation of ataxia in patients with the rare inherited disorder ataxia-telangiectasia. The approval introduces the first FDA-authorised therapy specifically targeting ataxia in this patient population, addressing an area that previously lacked an approved treatment. Field Content Alert Type Approval Drug Name Levacetylleucine Brand Name Aqneursa Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval Indication Treatment of ataxia in adults and paediatric patients with ataxia-telangiectasia weighing at least 15kg Therapy Area(s) Rare disease; neurology; genetic disease Technology or Modality Small-molecule therapy Geography United States What Happened The FDA approved Aqneursa (levacetylleucine) for treatment of ataxia in adults and children with ataxia-telangiectasia weighing at least 15kg. Why It Matters Aqneursa is the first FDA-approved treatment specifically addressing the neurological symptom of ataxia in patients with this rare genetic disorder. Supporting Context Ataxia-telangiectasia is an inherited multisystem disorder characterised by progressive neurological impairment, including worsening coordination and balance. Key Takeaway Aqneursa introduces the first FDA-approved therapy specifically for ataxia associated with ataxia-telangiectasia. What to Watch Clinical uptake, access for eligible paediatric and adult patients and longer-term evidence on neurological outcomes. Primary Source U.S. Food and Drug Administration Relevant Date 18 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Sandoz and mAbxience have entered a global collaboration to develop, manufacture and commercialise a proposed biosimilar to Roche's haemophilia medicine Hemlibra. mAbxience will lead development and manufacturing of the emicizumab biosimilar, while Sandoz will hold exclusive commercialisation rights across most global markets. The agreement expands both companies' biosimilar portfolios and targets a major biologic franchise with estimated annual global sales of approximately $5.7 billion. Field Content Alert Type Deal Companies Sandoz; mAbxience Deal Type Biosimilar development, manufacturing and commercialisation agreement Asset or Company Proposed emicizumab biosimilar Reference Product Hemlibra Therapy Area(s) Haematology; haemophilia A Technology or Modality Biosimilar monoclonal antibody Reference Product Sales Approximately US$5.7 billion in annual global sales Deal Value Financial terms were not disclosed Geography Most global markets What Happened Sandoz and mAbxience entered an agreement covering development, manufacturing and commercialisation of a proposed emicizumab biosimilar referencing Hemlibra. Why It Matters The partnership targets a major haemophilia biologic and adds another high-value programme to the global biosimilar pipeline. Supporting Context mAbxience will lead development and manufacturing while Sandoz will be responsible for commercialisation across most markets. Strategic Rationale The companies combine mAbxience's development and production capabilities with Sandoz's global biosimilar commercial infrastructure. Potential Impact A successfully approved biosimilar could increase competition and expand access to emicizumab treatment for people with haemophilia A. Key Takeaway Sandoz and mAbxience are partnering globally on a proposed biosimilar to Hemlibra. What to Watch Clinical development, regulatory submissions and future market-entry timing relative to Hemlibra's exclusivity landscape. Primary Source mAbxience / Sandoz Relevant Date 21 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Akums has received Indian marketing approval for a fixed treatment kit combining vonoprazan, clarithromycin and amoxicillin for adults with Helicobacter pylori infection. The 14-day regimen combines a potassium-competitive acid blocker with two antibiotics to support eradication of H. pylori, a major cause of peptic ulcer disease and an established gastric cancer risk factor. The approval adds a new packaged treatment option in India for H. pylori eradication and may simplify delivery of guideline-based combination therapy. Field Content Alert Type Approval Product Vonoprazan, clarithromycin and amoxicillin combination kit Company Akums Drugs & Pharmaceuticals Regulatory Authority Indian regulatory authorities Approval Type Marketing approval Indication Treatment of Helicobacter pylori infection in adults Treatment Duration 14 days Therapy Area(s) Gastroenterology; infectious disease Technology or Modality Fixed treatment kit combining potassium-competitive acid suppression and dual antibiotic therapy Active Ingredients Vonoprazan; clarithromycin; amoxicillin Geography India What Happened Akums received marketing approval in India for a combination treatment kit containing vonoprazan, clarithromycin and amoxicillin for H. pylori infection. Why It Matters The kit packages acid suppression and dual antibiotic therapy into a single treatment regimen, potentially simplifying H. pylori eradication therapy. Supporting Context H. pylori infection is associated with peptic ulcer disease and increased risk of gastric malignancy, making effective eradication an important clinical objective. Key Takeaway Akums has secured Indian marketing approval for a 14-day vonoprazan-based H. pylori eradication regimen. What to Watch Commercial launch, pricing, prescribing uptake and comparative eradication rates versus proton-pump-inhibitor-based regimens. Primary Source ETPharma.com Relevant Date 22 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

AbbVie and Iambic have entered a multi-year collaboration to use artificial intelligence and computational drug discovery across immunology, neuroscience and oncology. The partnership will combine AbbVie's therapeutic expertise with Iambic's Enchant v3 and broader molecular-superintelligence platform to identify and optimise new small-molecule drug candidates. Iambic will receive an upfront payment and is eligible for development and commercial milestones plus tiered royalties, although detailed financial terms were not disclosed. Field Content Alert Type Deal Companies AbbVie; Iambic Therapeutics Deal Type Multi-year drug discovery collaboration Asset or Company Enchant v3 and Iambic molecular-superintelligence platform Therapy Area(s) Immunology; neuroscience; oncology Technology or Modality Artificial intelligence; computational drug discovery; small molecules Deal Value Upfront payment plus development and commercial milestones and tiered royalties; financial amounts not disclosed Geography Global What Happened AbbVie and Iambic entered a multi-year collaboration to apply Iambic's AI-driven discovery platform to selected targets across immunology, neuroscience and oncology. Why It Matters The agreement adds another major pharmaceutical partner to Iambic's platform and reflects growing use of AI to accelerate small-molecule discovery and optimisation. Supporting Context Iambic's Enchant platform is designed to integrate molecular structure, chemistry and biological data to predict properties and guide drug design. Strategic Rationale AbbVie gains access to specialised AI discovery capabilities while Iambic receives funding and potential downstream economics tied to successful programmes. Potential Impact The collaboration could shorten discovery cycles and expand the number of tractable targets across several high-value therapeutic areas. Key Takeaway AbbVie is partnering with Iambic to apply AI-driven drug discovery across immunology, neuroscience and oncology. What to Watch Selection of programme targets, candidate nominations and progression of AI-designed molecules into preclinical development. Primary Source AbbVie Relevant Date 21 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The FDA has approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on endocrine therapy. The combination pairs Lilly's oral selective estrogen receptor degrader imlunestrant with the CDK4/6 inhibitor abemaciclib for patients whose tumours carry an ESR1 mutation. The approval also includes Guardant360 CDx as a companion diagnostic, reinforcing the role of circulating tumour DNA testing in identifying patients for biomarker-directed breast cancer treatment. Field Content Alert Type Approval Drug Name Imlunestrant Brand Name Inluriyo Combination Therapy Verzenio (abemaciclib) Company Eli Lilly and Company Regulatory Authority U.S. Food and Drug Administration Approval Type Combination therapy approval Indication Adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on at least one line of endocrine therapy Therapy Area(s) Oncology; breast cancer Biomarker ESR1 mutation Companion Diagnostic Guardant360 CDx Technology or Modality Oral selective estrogen receptor degrader plus CDK4/6 inhibitor Geography United States What Happened The FDA approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. Why It Matters The approval introduces another biomarker-driven treatment option for patients whose cancers develop ESR1-mediated resistance to endocrine therapy. Supporting Context ESR1 mutations are a recognised mechanism of acquired resistance in hormone receptor-positive breast cancer and can be detected using circulating tumour DNA testing. Key Takeaway Inluriyo plus Verzenio is now an FDA-approved treatment option for ESR1-mutated advanced ER-positive, HER2-negative breast cancer. What to Watch Clinical adoption of ESR1 testing, use of Guardant360 CDx and positioning of the combination within later-line endocrine treatment pathways. Primary Source U.S. Food and Drug Administration Relevant Date 18 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The FDA has approved and Amneal has launched a 120 mg/0.5 mL lanreotide injection referencing Somatuline Depot, expanding competition in the US complex-injectables market. The product received Competitive Generic Therapy designation and is used in indications including acromegaly and gastroenteropancreatic neuroendocrine tumours. The immediate commercial launch gives clinicians and patients another lanreotide treatment option and supports Amneal's strategy of expanding its portfolio of complex generic and specialty injectable products. Field Content Alert Type Approval Drug Name Lanreotide injection Company Amneal Pharmaceuticals Regulatory Authority U.S. Food and Drug Administration Approval Type Generic drug approval and commercial launch Reference Product Somatuline Depot Strength 120 mg/0.5 mL Regulatory Designation Competitive Generic Therapy Indication Approved lanreotide indications including acromegaly and gastroenteropancreatic neuroendocrine tumours Therapy Area(s) Endocrinology; oncology; neuroendocrine tumours Technology or Modality Complex injectable generic Geography United States What Happened The FDA approved Amneal's lanreotide 120 mg/0.5 mL injection referencing Somatuline Depot, and the company launched the product immediately. Why It Matters The approval introduces additional competition in a complex injectable medicine used across endocrine and neuroendocrine tumour care. Supporting Context Lanreotide is a long-acting somatostatin analogue used in acromegaly and for management of certain gastroenteropancreatic neuroendocrine tumours. Potential Impact Additional competition may improve treatment availability and create greater pricing choice for healthcare providers and patients. Key Takeaway Amneal has secured FDA approval and launched a complex injectable lanreotide product referencing Somatuline Depot. What to Watch Commercial uptake, pricing and market share within the US lanreotide market. Primary Source Amneal Pharmaceuticals Relevant Date 18 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Telix Pharmaceuticals has agreed to acquire ITM in a major radiopharmaceutical transaction valued at $1.65 billion upfront, with up to a further $700 million linked to regulatory and commercial milestones. The combination brings together Telix's oncology-focused radiopharmaceutical portfolio with ITM's isotope production infrastructure and therapeutic development capabilities. The transaction is intended to create a larger vertically integrated radiopharmaceutical company with capabilities spanning isotope supply, drug development, manufacturing and commercialisation. Field Content Alert Type Deal Companies Telix Pharmaceuticals; ITM Deal Type Acquisition Asset or Company ITM Therapy Area(s) Oncology; nuclear medicine Technology or Modality Radiopharmaceuticals; radioligand therapy; medical isotopes Deal Value US$1.65 billion upfront on a cash-free/debt-free basis, plus up to US$700 million in contingent regulatory and commercial milestone payments Geography Global What Happened Telix agreed to acquire 100% of ITM in a transaction valued at US$1.65 billion upfront, with additional contingent payments linked to ITM-11. Why It Matters The transaction combines a commercial and clinical radiopharmaceutical portfolio with major isotope-production capabilities, increasing scale across the radiopharma value chain. Supporting Context ITM has established isotope-production infrastructure and a pipeline of radiopharmaceutical therapies, while Telix has built a growing portfolio of diagnostic and therapeutic nuclear-medicine products. Strategic Rationale Telix gains greater control over isotope supply, manufacturing and therapeutic development while expanding its oncology pipeline and global radiopharmaceutical infrastructure. Potential Impact The combined business could improve isotope security, accelerate development of new radioligand therapies and strengthen competition in the rapidly expanding radiopharmaceutical market. Key Takeaway Telix is acquiring ITM for US$1.65 billion upfront in a major transaction designed to create a vertically integrated global radiopharmaceutical company. What to Watch Regulatory approvals, transaction completion, integration of isotope-production operations and progress of ITM-11 against its contingent milestones. Primary Source Telix Pharmaceuticals Relevant Date 21 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Novo Nordisk and Orbis Medicines have entered a multi-target drug-discovery partnership worth up to $1.4 billion to develop orally bioavailable macrocycle medicines for cardiometabolic disease. The collaboration will use Orbis' AI-enabled nGen platform to identify macrocyclic drug candidates against targets that have historically been difficult to address with conventional small molecules. Orbis is eligible for upfront and milestone payments of up to $1.4 billion plus royalties, while Novo Nordisk will also make a strategic investment in the company. Field Content Alert Type Deal Companies Novo Nordisk; Orbis Medicines Deal Type Multi-target drug discovery and licensing partnership Asset or Company nGen macrocycle discovery platform Therapy Area(s) Cardiometabolic disease Technology or Modality Orally bioavailable macrocycles; AI-enabled drug discovery Deal Value Up to US$1.4 billion in upfront and milestone payments, plus royalties and a strategic equity investment Geography Global What Happened Novo Nordisk and Orbis Medicines entered a multi-target partnership to discover and develop orally bioavailable macrocycle medicines for cardiometabolic diseases. Why It Matters The deal gives Novo access to a platform designed to create oral medicines against targets that are difficult to address using conventional small-molecule approaches. Supporting Context Orbis' nGen platform combines high-throughput macrocycle synthesis and artificial intelligence to identify orally bioavailable compounds with properties traditionally associated with larger biologic drugs. Strategic Rationale Novo Nordisk gains access to a differentiated discovery technology while Orbis secures substantial development economics and validation of its macrocycle platform. Potential Impact Successful programmes could expand the range of cardiometabolic targets that can be treated with convenient oral medicines. Key Takeaway Novo Nordisk is committing up to US$1.4 billion to an Orbis Medicines macrocycle discovery partnership focused on cardiometabolic disease. What to Watch Target selection, candidate nomination and progression of the first nGen-derived programmes into preclinical development. Primary Source Orbis Medicines Relevant Date 17 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Viatris has received Japanese approval for Wakix to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea. Wakix, or pitolisant, is the first histamine H3 receptor antagonist and inverse agonist approved in Japan for these indications and provides a non-stimulant approach to improving wakefulness. The approval expands the international reach of Wakix and introduces a new mechanism of action for patients in Japan with disabling excessive daytime sleepiness. Field Content Alert Type Approval Drug Name Pitolisant Brand Name Wakix Company Viatris Regulatory Authority Japanese regulatory authorities Approval Type Marketing approval Indication Narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea Therapy Area(s) Neurology; sleep medicine Technology or Modality Histamine H3 receptor antagonist/inverse agonist Geography Japan What Happened Viatris received Japanese approval for Wakix for narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea. Why It Matters Wakix introduces a first-in-class, non-stimulant wake-promoting mechanism to the Japanese market for patients affected by significant daytime sleepiness. Supporting Context Pitolisant enhances histaminergic activity in the brain through H3 receptor antagonism and inverse agonism and is already used in other international markets. Key Takeaway Wakix becomes Japan's first approved H3 receptor antagonist/inverse agonist for narcolepsy and excessive daytime sleepiness associated with OSA. What to Watch Japanese commercial launch, reimbursement, prescribing patterns and adoption across sleep-medicine centres. Primary Source Viatris Relevant Date 16 September 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com