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FDA+ channel feed
Ahead of adcomm, FDA discusses Seikagaku's mixed trial results for its lumbar disc herniation injection
6 months ago
After a bump in adcomms in 2023, FDA advisory panels returned to 2022 levels
6 months ago
FDA sets an efficacy threshold for future weight loss drugs
6 months ago
Drugmakers cut some list prices, shrinking room for rebates in cancer, asthma and diabetes
6 months ago
Pharma
FDA offers suite of new guidance on AI, accelerated approvals, clinical trials and more
6 months ago
Every FDA drug approval from 2024: Fewer nods, but long-awaited treatments cross the finish line
6 months ago
Pharma
Florida car dealer joins insulin pricing fight against Eli Lilly, Sanofi
6 months ago
Pharma
Law
Novo petitions FDA over Victoza compounding as first generic wins approval
6 months ago
Pharma
Pennsylvania Blue Cross insurer restricts coverage of medicines granted FDA accelerated approval
6 months ago
FDA adcomm to review Novartis' Fabhalta in ultra-rare kidney disease
6 months ago
R&D
FDA approves subcutaneous version of Bristol Myers' Opdivo
6 months ago
Pharma
Federal appeals court says Teva must delist Orange Book inhaler patents
6 months ago
Pharma
Law
Three drugmakers sue US over 340B discounts to STD clinics they allege don’t qualify
6 months ago
Law
Viatris' India-based manufacturing site blocked from shipping 11 generic drugs to US
6 months ago
Pharma
Sumitomo’s overactive bladder drug adds another indication
6 months ago
Pharma
PDUFAs for Tonix and Nuvation; Sanofi vaccine partnership; RAPT allergy deal
6 months ago
Deals
News Briefing
FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market
6 months ago
Pharma
Novo Nordisk’s once-daily hemophilia drug Alhemo approved in US
6 months ago
Pharma
Vertex gets 'vanza triple' approval and Trikafta expansion — with boxed warnings
6 months ago
Pharma
PBM reform unlikely to attach to short-term spending bill as shutdown looms
6 months ago
Pharma
Accelerated approval brings Pfizer's BRAF inhibitor to first-line patients
6 months ago
Pharma
Califf, on his way out at FDA, predicts agency tug-of-war between Ramaswamy and RFK Jr.
6 months ago
Rhythm receives expanded approval for genetic obesity drug
6 months ago
Pharma
FDA approves Humacyte’s lab-grown blood vessels in milestone for regenerative medicine
6 months ago
R&D
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