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The FDA has approved copper histidinate (Zycubo) for the treatment of Menkes disease, addressing a long-standing unmet need in this rare genetic neurological condition. The U.S. Food and Drug Administration (FDA) has approved copper histidinate (Zycubo) for the treatment of Menkes disease, a rare genetic neurological condition. This decision addresses a long-standing unmet medical need, marking the first targeted therapy for patients with this life-limiting disorder. Alert Type Drug Approval Drug Name Zycubo Indication Menkes disease Therapy Area(s) Neurology Geography US (FDA) What Changed FDA approved Zycubo (copper histidinate) for treatment of Menkes disease on 12/1/2026. This provides the first targeted therapy for this rare genetic disorder. Clinical Relevance Offers a potentially life-altering therapy for patients with Menkes disease, addressing a previously unmet medical need. Source Link https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 Date 12th Jan 2026 Status Draft Notes Pediatric population; post-marketing studies may be ongoing. 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

First-in-class B-cell therapy now available as an add-on treatment for adults with gMG, supported by Phase III MINT trial outcomes. The European Commission has approved Uplizna (inebilizumab) as an add-on therapy for adults with generalised myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. This approval, supported by the Phase III MINT trial, provides a first-in-class B-cell therapy with twice-yearly maintenance dosing and potential to reduce long-term steroid use, broadening treatment options for both AChR+ and MuSK+ patients. Field Completed for Uplizna (inebilizumab) Alert Type Drug Approval (EC) Drug Name Uplizna (inebilizumab) Indication Add-on treatment for adults with generalised myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive Therapy Area(s) Neurology / Immunology Geography EU (European Commission) What Changed The European Commission approved Uplizna as an add-on therapy for adults with generalised myasthenia gravis (gMG) who are antibody positive, following positive outcomes from the Phase III Myasthenia Gravis Inebilizumab Trial (MINT). Clinical Relevance Uplizna provides a new first-in-class B-cell targeted treatment for gMG, offering twice-yearly maintenance dosing and potential decrease in long-term steroid use, broadening therapeutic options for AChR+ and MuSK+ patients. Source Link Global Data Date 13-Feb-2026 Status Draft Notes Supported by the Phase III MINT trial, which included structured steroid tapering and both AChR+ and MuSK+ cohorts. Previously approved in EU for IgG4-related disease (Nov 2025) and for neuromyelitis optica spectrum disorder (AQP4-IgG+ adults). 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

Wearable TTFields device now authorised in combination with chemotherapy following Phase III PANOVA-3 trial demonstrating overall survival benefit. The FDA has approved Optune Pax, a wearable therapeutic device delivering Tumor Treating Fields (TTFields), for use with gemcitabine and nab-paclitaxel in adults with locally advanced pancreatic cancer. Approval is based on the Phase III PANOVA-3 trial, which demonstrated a statistically significant improvement in overall survival, delayed pain progression, and offers a novel non-invasive therapy option for a disease with historically limited treatment choices. Alert Type Medical Device Approval (FDA) Drug/Device Name Optune Pax Indication Treatment of adult patients with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel Therapy Area(s) Oncology Geography US (FDA) What Changed The U.S. FDA has approved the Optune Pax wearable therapeutic device — delivering Tumor Treating Fields (TTFields) — for use with chemotherapy in adults with locally advanced pancreatic cancer. The decision was based on statistically significant overall survival benefit in the Phase III PANOVA-3 trial. Clinical Relevance Adds a novel non-invasive device-based therapy to standard chemotherapy for a disease with historically limited options, showing improved overall survival and delayed pain progression. Source Link https://firstwordpharma.com/story/7103267 Date 13-Feb-2026 Status Draft Notes Approval is through the FDA’s PMA pathway; TTFields are alternating electric fields targeting cancer cell division; trial enrolled 571 patients showing OS benefit. 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

Positive opinion based on Phase 3 BRAVE-AA-PEDS trial supports first-in-class JAK inhibitor therapy for young patients with profound hair loss. The CHMP has issued a positive opinion for Olumiant (baricitinib) for adolescents with severe alopecia areata, following Phase 3 BRAVE-AA-PEDS data showing 42% achieved ≥80% scalp hair coverage at 36 weeks. If approved by the European Commission, Olumiant will offer the first evidence-based therapy specifically for this vulnerable population, addressing significant social and emotional impact of early-onset AA. Alert Type Drug Approval (CHMP positive opinion) Drug/Device Name Olumiant (baricitinib) Indication Treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA) Therapy Area(s) Dermatology / Immunology Geography EU (EMA / CHMP) What Changed CHMP issued a positive opinion recommending Olumiant for approval in adolescents with severe AA, based on the Phase 3 BRAVE-AA-PEDS trial showing 42% of patients achieved ≥80% scalp hair coverage at 36 weeks. The opinion will now be reviewed by the European Commission for final approval. Clinical Relevance Provides a first-in-class JAK inhibitor therapy for adolescents with severe AA, a population with limited treatment options, supporting hair regrowth on the scalp, eyebrows, and eyelashes while maintaining a manageable safety profile. Source Link PR Newswire / GlobalData Date 27-Feb-2026 Status Draft Notes BRAVE-AA-PEDS is the first and largest Phase 3 trial for adolescents with severe AA; efficacy includes scalp, eyebrow, and eyelash regrowth; U.S. submission is pending with decision expected H2 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

Combination therapy demonstrates significant improvements in progression-free and overall survival in adults after at least one prior treatment, offering a new standard-of-care option. The U.S. FDA has approved Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. Approval is based on the Phase III MajesTEC-3 trial, which demonstrated significant improvements in progression-free survival, overall survival (83.3% vs 65% at 3 years), and response rates, with manageable safety and low discontinuation rates. Alert Type Drug Approval (FDA) Drug/Device Name Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab and hyaluronidase-fihj) Indication Treatment of adults with relapsed or refractory multiple myeloma (r/r MM) who have received at least one prior therapy including a proteasome inhibitor and an immunomodulatory agent Therapy Area(s) Haematology / Oncology Geography US (FDA) What Changed The FDA approved Tecvayli in combination with Darzalex Faspro for adults with r/r MM, based on the Phase III MajesTEC-3 trial showing significant improvements in progression-free survival, overall survival, and response rates compared to standard regimens. Clinical Relevance Provides a new standard-of-care combination therapy for r/r MM, with robust efficacy (OS 83.3% vs 65% at 3 years) and manageable safety, expanding treatment options for patients after at least one prior therapy. Source Link https://www.jnj.com/latest-news/johnson-johnson-receives-fda-approval-for-tecvayli-combination-therapy-in-relapsed-refractory-multiple-myeloma Date 13-Feb-2026 Status Draft Notes Approval supported by ongoing Phase III MajesTEC-3 study; breakthrough therapy designation, Commissioner’s National Priority Voucher, and real-time oncology review; adverse events mainly cytopenias and infections, low discontinuation rates; cytokine release syndrome mostly Grade 1/2. 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

China authorises the first cAMP-biased GLP-1 receptor agonist for obesity, following robust Phase III SLIMMER trial results. The National Medical Products Administration (NMPA) has approved ecnoglutide for chronic weight management in adults with overweight or obesity, supported by Phase III SLIMMER trial data showing a placebo-adjusted mean weight reduction of 15.1% at 48 weeks and 92.8% of patients achieving clinically meaningful ≥5% weight loss. This marks the first global approval of a cAMP-biased GLP-1 receptor agonist for obesity, providing a potent new option for sustained weight loss with efficacy comparable to semaglutide (Wegovy). Alert Type Drug Approval (NMPA) Drug/Device Name Ecnoglutide Indication Chronic weight management in adults with overweight or obesity Therapy Area(s) Endocrinology / Metabolic Disease Geography China (NMPA) What Changed The NMPA approved ecnoglutide for chronic weight management in adults with overweight or obesity, following Phase III SLIMMER trial data showing a placebo-adjusted mean weight reduction of 15.1% at 48 weeks and 92.8% of patients achieving ≥5% weight loss. Clinical Relevance Introduces the first cAMP-biased GLP-1 receptor agonist for obesity in China, providing a potent new option for sustained weight loss with efficacy comparable to semaglutide (Wegovy). Source Link https://www.firstwordpharma.com/story/7103268 Date 27-Feb-2026 Status Draft Notes Second regulatory authorisation (previously approved for T2D as Xianyida, Jan 2026); Pfizer secured commercialisation rights in China in a $495M deal; demonstrates continued weight loss at 48 weeks without plateau; first global approval for a cAMP-biased GLP-1 receptor agonist in obesity. 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

A Small Group of Specialties Continues to Pull Away From the Rest The latest physician compensation data highlights a clear structural reality within healthcare: earnings are not evenly distributed, and a small group of specialities continues to dominate the top end of the market. At the highest level, procedure-led fields such as neurosurgery, orthopaedic surgery and cardiology consistently command the strongest salaries. Average earnings in these areas comfortably exceed $500,000 per year, creating a significant gap with the rest of the profession. The Scale of the Gap Tier Specialty Average Compensation Top Neurosurgery $749,140 Top Thoracic Surgery $689,969 Top Orthopaedic Surgery $679,517 Top Plastic Surgery $621,445 Top Cardiology $587,360 Mid Emergency Medicine $411,133 Mid Obstetrics & Gynecology $389,566 Mid Psychiatry $341,977 Lower Internal Medicine $326,116 Lower Family Medicine $318,959 Lowest Endocrinology $290,606 Lowest Pediatrics $265,230 The drop-off is immediate. Once you move away from procedure-heavy specialties, compensation compresses into a much narrower band. The majority of physicians operate within this middle tier, rather than at the top. Compensation Is Driven by Type of Work, Not Volume of Demand One of the more revealing aspects of the data is that compensation is not aligned with demand. In fact, many of the most widely recruited specialties sit outside the highest-paying bracket. Salary Distribution by Specialty Type Salary Band Example Specialties $500k–$750k Neurosurgery, Orthopaedics, Cardiology, Radiology $400k–$500k Emergency Medicine, OB/GYN, Pulmonology $300k–$400k Psychiatry, Internal Medicine $250k–$300k Pediatrics, Endocrinology, Geriatrics Primary care fields—despite being critical to healthcare systems—sit at the lower end of the pay spectrum. Meanwhile, highly specialised, procedure-driven roles continue to command a premium. This highlights a key dynamic: "Earnings are shaped more by the nature of the work than by the role's demand" Growth and Pay Do Not Always Move Together Another important trend is the disconnect between compensation and growth. Some of the fastest-growing specialties are not the highest paid, suggesting that market demand is not being matched by financial incentives . Fastest Growing Specialties vs Pay Specialty Growth Rate Average Pay Pediatric Nephrology +15.6% $263,013 Preventive Medicine +10.0% $310,177 Radiology +7.5% $571,749 Hematology +7.4% $421,482 Family Medicine +6.0% $318,959 While radiology sits at both the high-growth and high-pay end, most other fast-growing specialties remain in the middle or lower compensation tiers. This creates a structural imbalance, where areas of increasing need are not necessarily the ones that offer the strongest financial returns. Where Doctors Work Also Shapes What They Earn Compensation is influenced not only by speciality but also by practice setting. The structure of employment plays a meaningful role in determining earning potential. Compensation by Practice Setting Practice Setting Average Compensation Single Specialty Group $476,807 Multi-Specialty Group $461,671 Solo Practice $457,562 Hospital $439,319 Academic $382,223 Government $303,385 Doctors working in private or specialised group settings tend to earn more than those in academic or government roles, where salaries are typically more standardised. What This Means for the Healthcare Market Taken together, the data paints a clear picture of how value is distributed within healthcare. A relatively small group of specialties, those tied to complex, revenue-generating procedures, continue to capture a disproportionate share of total earnings. Meanwhile, the majority of physicians operate in essential, high-demand roles that are comparatively less well compensated. For organisations operating in healthcare, this has direct implications for recruitment, retention and long-term workforce planning. Understanding where compensation is concentrated and why offers a clearer view of the pressures shaping the system. It is not simply a question of who earns the most but how the structure of healthcare itself determines where financial value is created. Source - Doximity Physician Compensation Report 2025 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

Aldeyra Therapeutics’ new drug application for reproxalap was not approved due to insufficient clinical trial data demonstrating efficacy. The FDA issued a complete response letter for reproxalap, citing inconsistencies in the clinical trial results and insufficient evidence of its effectiveness for dry eye disease. Aldeyra Therapeutics will request a Type A meeting with the agency to discuss potential pathways forward, while no additional trials are currently required. Alert Type Complete Response Letter (FDA) Drug/Device Name Reproxalap Indication Dry eye disease Therapy Area(s) Ophthalmology Geography US (FDA) What Changed The FDA issued a complete response letter for Aldeyra Therapeutics’ NDA for reproxalap, citing insufficient evidence of efficacy and inconsistencies in clinical trial results under the proposed conditions of use. Clinical Relevance Reproxalap’s effectiveness remains unproven; further guidance from the FDA will be required before potential market access. Source Link https://www.globaldata.com/newsletter/details/fda-issues-crl-to-aldeyra-s-reproxalap-drug-application_380478 Date 27-Feb-2026 Status Draft Notes FDA recommended exploring reasons for trial failures and identifying responsive populations; no new trials required. Aldeyra plans a Type A meeting within 30 days. Company cash position as of 31-Dec-2025: $70m, supporting operations into 2028. 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 collaboration leverages Trialing’s platform to connect physicians with early-phase cancer studies and provide real-time updates on patient enrolment opportunities. START’s partnership with Trialing aims to streamline referrals and increase physician awareness of ongoing oncology trials, improving patient access to innovative therapies. By sharing dynamic study information and eligibility updates, the initiative supports faster, more transparent connections between physicians and clinical trial sites across Europe. Alert Type Clinical Trial / Partnership Drug/Device Name N/A – Clinical Trial Access Platform Indication Oncology – Early-phase cancer trials Therapy Area(s) Haematology / Oncology Geography Europe What Changed START Center for Cancer Research has partnered with Trialing to improve access to early-phase oncology trials across Europe, leveraging Trialing’s platform to connect physicians with active studies and notify them of patient enrolment opportunities. Clinical Relevance Enhances referral pathways, increases physician awareness of ongoing trials, and enables real-time updates on eligibility and enrolment, improving patient access to innovative cancer therapies. Source Link START Press Release Date 09-Mar-2026 Status Draft Notes Trialing’s platform supports rapid study identification using structured decision pathways; START continues to expand its European trial network and has prior collaborations, including Fundación Rioja Salud in Spain. 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

Phase III GLISTEN trial data supports approval of the first therapy specifically targeting cholestatic pruritus in PBC patients. The FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, marking the first dedicated therapy for this debilitating symptom. Backed by Phase III GLISTEN trial results, the drug demonstrated rapid and sustained improvements in itch and sleep interference, addressing a significant unmet need in liver disease management. Alert Type Drug Approval (FDA) Drug/Device Name Lynavoy (linerixibat) Indication Cholestatic pruritus in patients with primary biliary cholangitis (PBC) Therapy Area(s) Hepatology / Liver Disease Geography US (FDA) What Changed The FDA approved Lynavoy, the first therapy for cholestatic pruritus linked to PBC, following Phase III GLISTEN trial results showing rapid and sustained improvement in itch and sleep interference compared to placebo. Clinical Relevance Provides the first dedicated treatment for PBC-related itch, addressing a previously unmet symptom with significant impact on patient quality of life. Source Link https://www.gsk.com/en-gb/media/press-releases/fda-approves-lynavoy-for-pruritus-in-pbc/ Date 19-Mar-2026 Status Draft Notes GLISTEN Phase III trial met primary and key secondary endpoints; market competition includes PPAR agonists Livdelzi (seladelpar) and Iqirvo (elafibranor); Alfasigma licensing deal includes upfront $300M, $100M on approval, plus EU/UK milestones and royalties; Lynavoy under review in EU and UK; first liver medicine from GSK’s pipeline to receive approval. 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

Artificial intelligence is rapidly transforming healthcare, but its success depends on more than algorithm, it also depends on humans. At Doximity’s annual AI Medical Summit, it has become clear that AI’s greatest potential lies in enhancing physicians’ work, not replacing them. Key Takeaways from the Summit: Opportunities and Limitations: AI in clinical medicine has enormous potential, but its effectiveness hinges on context and thoughtful deployment. Physicians in the Driver’s Seat: Doctors must guide how AI tools are used. Their expertise ensures that AI safely and meaningfully augments clinical decisions. Enhancing Patient Care: AI can become a “care partner,” improving the patient-doctor relationship by handling routine tasks and providing actionable insights. Tailored Tools for Real-World Medicine: Doximity’s portfolio—including Scribe, Dialer, and DoxGPT—demonstrates how AI can meet the evolving demands of modern medicine. PeerCheck Innovation: DoxGPT’s PeerCheck allows AI recommendations to be corroborated by expert human input, creating trustworthy outputs that clinicians can rely on. A “Physician First” Philosophy: At its core, Doximity prioritises the needs of physicians, designing tools by doctors, for doctors. Highlighting that Doximity isn’t just a platform. It’s a physician-led approach to integrating AI into healthcare. By keeping doctors at the centre, these tools aim to support clinical work, reduce administrative burden, and allow clinicians to focus on patient care with trust and empathy. 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

Merck has agreed to acquire biotechnology company Terns Pharmaceuticals in a deal valued at approximately $6.7 billion, strengthening its oncology pipeline ahead of the upcoming patent expiry of its blockbuster drug, Keytruda. The acquisition centres around TERN-701, an experimental treatment for chronic myeloid leukaemia currently in clinical development. The drug has shown promising early results and could become a major revenue driver if approved. Preparing for the Keytruda Patent Cliff The strategic motivation behind the deal is clear. Keytruda is one of the world’s best-selling drugs and generates tens of billions in annual revenue for Merck. However, key patent protections begin to expire in 2028, creating a potential revenue gap. Large pharmaceutical companies often respond to these “patent cliffs” by acquiring late-stage drugs or biotechnology companies with promising pipelines. The Terns acquisition appears to be part of Merck’s broader strategy to replace future lost revenue with new oncology products. A Wider Industry Trend This deal is part of a wider trend across the pharmaceutical industry. Many major drugmakers are increasingly acquiring smaller biotech companies rather than relying solely on internal research and development. This approach allows them to access new technologies, pipelines and therapeutic areas more quickly. Oncology remains the most active area for pharmaceutical acquisitions, with companies investing heavily in targeted therapies, immunotherapies and rare cancer treatments. What This Means for the Industry The Merck–Terns deal highlights three major trends in pharma: Companies are preparing for major patent expiries Oncology remains the top investment area Big pharma increasingly buys innovation from biotech rather than building it internally As patent cliffs approach for several blockbuster drugs across the industry, further acquisitions and licensing deals are likely over the next few years. Summary As Merck moves to secure its next generation of oncology treatments, this acquisition underscores the growing importance of strategic biotech partnerships for big pharma to stay ahead in an increasingly competitive, patent‑driven market. 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