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FDA approves SimpleScreen™ CRC blood test for colorectal cancer screening in average-risk adults
The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening.

nuaxia
1 day ago2 min read


FDA approves Tylenol with Naproxen as the first non-prescription fixed-dose acetaminophen and naproxen sodium combination
The approval provides adults and children aged 12 years and older with a single over-the-counter combination option that delivers both rapid and prolonged pain relief without requiring separate analgesic products.

nuaxia
2 days ago2 min read


CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic breast cancer
If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer.

nuaxia
3 days ago2 min read


EMA recommends Icotyde for EU authorisation in moderate-to-severe plaque psoriasis
If authorised, Icotyde would become the first oral treatment targeting the interleukin-23 receptor available to eligible adults and adolescents in the EU.

nuaxia
3 days ago2 min read


FDA approves Simtriyo for ADHD in adults and children aged 6 years and older
The once-daily treatment introduces the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, with US availability dependent on DEA scheduling.

nuaxia
3 days ago2 min read


FDA advisory panel recommends four peptides for 503A compounding list
The non-binding recommendation could create a regulated US compounding route for BPC-157, KPV, TB-500 and MOTS-c, but it does not approve the substances as drugs or establish their safety or effectiveness.

nuaxia
6 days ago2 min read


FDA grants orphan drug designation to AFTX-201 for BAG3-associated dilated cardiomyopathy
The designation supports development of a one-time investigational gene therapy designed to address the underlying genetic cause of a rare form of dilated cardiomyopathy.

nuaxia
Jul 232 min read


Donald Trump announces phased tariffs on imported generic drugs from 2028
The two-year tariff-free window could prompt overseas manufacturers and US importers to reassess production, investment and sourcing before higher duties take effect.

nuaxia
Jul 222 min read


FDA approves Lipfendra as the first oral PCSK9 inhibitor for high cholesterol
The once-daily tablet provides a new oral option for reducing LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia.

nuaxia
Jul 211 min read


UK Biotech Financing Hits Five-Year High as Venture Capital Momentum Accelerates
Strong private investment signals renewed confidence in the UK life sciences sector, but public markets remain a challenge.

nuaxia
Jul 203 min read


Sanofi and Lilly Back AdvanCell’s $315M Radiopharmaceutical Expansion as ADVC001 Moves Towards Late-Stage Development
Funding round will support development of lead targeted alpha therapy ADVC001 in metastatic prostate cancer and expand Lead-212 manufacturing capabilities.

nuaxia
Jul 173 min read


Merck’s Lipfendra Becomes First FDA-Approved Oral PCSK9 Inhibitor for High Cholesterol
Oral cholesterol therapy offers an alternative to injectable PCSK9 inhibitors as Merck targets multi-billion-dollar cardiovascular market.

nuaxia
Jul 173 min read


FDA Approves Celcuity’s Revtorpyk for PI3K-Pathway Targeted Breast Cancer Treatment
The approval of Revtorpyk (gedatolisib) gives Celcuity a new treatment option for HR-positive, HER2-negative breast cancer patients without PIK3CA mutations, following positive Phase III VIKTORIA-1 data showing improved progression-free survival.

nuaxia
Jul 153 min read


Biogen Advances Tau-Targeting Alzheimer’s Drug Diranersen Despite Phase II Dose Uncertainty
Detailed CELIA trial results show Biogen and Ionis’ diranersen slowed cognitive decline in early Alzheimer’s disease, but questions remain over why the lowest dose delivered the strongest clinical benefit.

nuaxia
Jul 154 min read


Claria Medical Secures FDA De Novo Clearance for Hysterectomy Tissue Extraction System
The Claria System is designed to improve safety and efficiency during minimally invasive hysterectomy procedures by providing a controlled tissue extraction approach.

nuaxia
Jul 143 min read


Insilico Medicine and China Medical System Expand AI Drug Discovery Partnership with $177m CNS Deal
The latest agreement strengthens the companies’ collaboration as they target a major central nervous system indication using AI-powered drug discovery.

nuaxia
Jul 143 min read


Bayer Secures €3bn Apollo Investment in Contraceptives Business as Pharma Strategy Evolves
The deal gives Bayer additional financial flexibility while allowing the company to retain operational control of its long-acting reversible contraceptives portfolio.

nuaxia
Jul 133 min read


FDA Clears iHealthScreen’s AI Diabetic Retinopathy Screening Software
iPredict-DR uses artificial intelligence to analyse retinal images and support earlier detection of diabetic eye disease.

nuaxia
Jul 133 min read


FDA Clears Zeta Surgical’s AI-Powered Robotic TMS Navigation System for Treatment-Resistant Depression
Zeta Surgical’s robotic navigation platform uses AI and computer vision to improve precision and repeatability during transcranial magnetic stimulation procedures.

nuaxia
Jul 133 min read


FDA Approves MSD’s Keytruda Combinations with Padcev for Muscle-Invasive Bladder Cancer
The approvals expand the use of Keytruda and Keytruda Qlex alongside Padcev into the perioperative treatment setting for adults with muscle-invasive bladder cancer.

nuaxia
Jul 134 min read
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