Top Trump lawyer calls on SCOTUS to reverse 'skinny' generic drug label decision
President Donald Trump's Solicitor General John Sauer has called on the Supreme Court to take up a case that could discourage generic drugmakers from seeking approvals without all of the indications on...
View ArticleGSK's new antibiotic wins gonorrhea approval
GSK won a label expansion on Thursday for its oral antibiotic Blujepa to treat uncomplicated urogenital gonorrhea. The twice-daily pill is approved for adults and children 12 years and older who weigh...
View ArticleEU forges deal over major pharma legislative changes
The European Council and Parliament on Thursday said that they reached agreement on a new set of pharmaceutical industry reforms — the first in two decades. But an industry group argues the deal will...
View ArticleGeron cuts one-third of staff, focusing on turning Rytelo launch around
Geron is cutting one-third of its 260-person staff — about 87 employees — in a restructuring led by the California biopharma's new CEO. The announcement comes as Geron retools its launch efforts for...
View ArticleCDC report underscores benefit of Covid-19 vaccines in kids
A new CDC report highlights the benefit of the Covid-19 vaccines at preventing infection-related hospital visits for kids, while the FDA continues to review the safety of the same products. The data,
View ArticleCentessa CEO to step down; John Maraganore, Clive Meanwell find CMO for their...
→ Centessa Pharmaceuticals president Mario Alberto Accardi will take over as CEO on Jan. 1. Saurabh Saha has held the top spot since its splashy $250 million ...
View ArticleFDA broadens label for Amgen's Uplizna as it enters rare disease competition
The FDA on Thursday expanded the label for Amgen’s rare disease drug Uplizna, approving it in an autoimmune disorder that’s quickly become a hot — and crowded — area for biopharma. Regulators gave the...
View ArticleTenaya targets $60M offering after heart disease pipeline updates
Tenaya Therapeutics, a company focused on developing gene therapies for heart conditions, made a series of announcements on Thursday. The biotech said the FDA has lifted a partial hold on one of its...
View ArticleGSK spins out corporate VC fund focused on bioelectronic tech
GSK has offloaded a corporate venture unit that invests in bioelectronic startups working on neuromodulation, wearables, implanted devices and other technology, Endpoints News has learned. The VC unit,...
View ArticleInnovent’s obesity drug data in adolescents; Everest gets rights to PCSK9...
Plus, news about BioCryst, Cycle Pharma, Applied Therapeutics, Contineum Therapeutics, Juncell Therapeutics, Cosette and Mayne Pharma: 📊 Innovent’s mazdutide shows early promise in adolescents: The...
View ArticleArcus, Gilead report Phase 3 TIGIT failure in upper GI cancers
Another TIGIT program has failed in the clinic, this time in a Phase 3 study. Arcus and Gilead said on Friday that their anti-TIGIT antibody domvanalimab, when combined with an experimental anti-PD-1...
View Article#SABCS25: Celcuity further details Phase 3 win; Relay’s PI3Kα inhibitor’s...
Roche and BioNTech stole the show at this year’s San Antonio Breast Cancer Symposium. The Swiss drugmaker unveiled Phase 3 data for its oral SERD giredestrant, showing the drug slashed the risk ...
View ArticleCHMP calls to reject Anavex's Alzheimer’s pill over impurities, side effects...
As part of a batch of recommendations issued Friday, the European Medicines Agency’s human medicines committee (CHMP) recommended rejecting Anavex’s Alzheimer’s disease drug, issuing a scathing review...
View ArticleA 2-speed payer transformation is underway
Health insurers are facing two colliding forces heading into 2026: Medical costs are challenging the way they do business, and major technology shifts are finally starting to reshape the industry....
View ArticleCovid vaccine deaths review sent to top of FDA, but with far less certain...
An FDA staff analysis of the safety of pediatric Covid-19 shots has been finalized and sent to the agency’s vaccine and biologics head Vinay Prasad. But the report comes to many fewer firm conclusions...
View Article340B sales grew 23% last year, and court battle over pilot program intensifies
Eligible health centers purchased $81.4 billion in discounted drugs under the federal 340B program in 2024, an increase of 23% from the previous year as the program continues to expand — and face legal...
View ArticleEli Lilly’s triple-G obesity readout; The latest Endpoints 100 results;...
Welcome back to another edition of Endpoints Weekly. We’re barreling toward the holiday season, which means it’s time for an early programming note: Our newsletters will go dark between Dec. 24 and...
View ArticleMilestone finally wins FDA approval for arrythmia nasal spray
Milestone Pharmaceuticals’ nasally administered emergency treatment for a form of heart arrythmia has been approved by the FDA, after being knocked back twice before. The drug, named Cardamyst...
View ArticleSobi to buy gout biotech Arthrosi for $950M upfront
Sobi plans to buy Arthrosi Therapeutics, a Phase 3 gout biotech, for $950 million upfront and as much as $550 million in additional milestones, the Swedish drugmaker said Saturday. The Arthrosi ...
View ArticleArgenx cans thyroid eye disease trials of Vyvgart Hytrulo
Argenx said Monday it will stop late-stage trials of its autoimmune disease shot Vyvgart Hytrulo in thyroid eye disease after an interim analysis found the studies were unlikely to succeed. The...
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