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FDA+ channel feed
Pfizer touts bladder cancer results as first advancement for some patients 'in decades'
4 months ago
R&D
Pharma
Updated: CDER Director Patrizia Cavazzoni to step down ahead of Trump presidency
4 months ago
People
Bayer says elinzanetant quelled hot flashes in women undergoing cancer treatment
4 months ago
R&D
Pharma
Catalyst staves off Firdapse competition from Teva for a decade
4 months ago
Law
Pfizer, GSK add risk of Guillain-Barré to RSV vaccine labels at FDA's request
4 months ago
R&D
Ahead of adcomm, FDA discusses Seikagaku's mixed trial results for its lumbar disc herniation injection
4 months ago
After a bump in adcomms in 2023, FDA advisory panels returned to 2022 levels
4 months ago
FDA sets an efficacy threshold for future weight loss drugs
4 months ago
Drugmakers cut some list prices, shrinking room for rebates in cancer, asthma and diabetes
4 months ago
Pharma
FDA offers suite of new guidance on AI, accelerated approvals, clinical trials and more
4 months ago
Every FDA drug approval from 2024: Fewer nods, but long-awaited treatments cross the finish line
4 months ago
Pharma
Florida car dealer joins insulin pricing fight against Eli Lilly, Sanofi
4 months ago
Pharma
Law
Novo petitions FDA over Victoza compounding as first generic wins approval
4 months ago
Pharma
Pennsylvania Blue Cross insurer restricts coverage of medicines granted FDA accelerated approval
4 months ago
FDA adcomm to review Novartis' Fabhalta in ultra-rare kidney disease
4 months ago
R&D
FDA approves subcutaneous version of Bristol Myers' Opdivo
4 months ago
Pharma
Federal appeals court says Teva must delist Orange Book inhaler patents
5 months ago
Pharma
Law
Three drugmakers sue US over 340B discounts to STD clinics they allege don’t qualify
5 months ago
Law
Viatris' India-based manufacturing site blocked from shipping 11 generic drugs to US
5 months ago
Pharma
Sumitomo’s overactive bladder drug adds another indication
5 months ago
Pharma
PDUFAs for Tonix and Nuvation; Sanofi vaccine partnership; RAPT allergy deal
5 months ago
Deals
News Briefing
FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market
5 months ago
Pharma
Novo Nordisk’s once-daily hemophilia drug Alhemo approved in US
5 months ago
Pharma
Vertex gets 'vanza triple' approval and Trikafta expansion — with boxed warnings
5 months ago
Pharma
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