FDA+ channel feed – Endpoints News

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

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

Florida car dealer joins insulin pricing fight against Eli Lilly, Sanofi

6 months ago

Novo petitions FDA over Victoza compounding as first generic wins approval

6 months ago

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

FDA approves subcutaneous version of Bristol Myers' Opdivo

6 months ago

Federal appeals court says Teva must delist Orange Book inhaler patents

6 months ago

Three drugmakers sue US over 340B discounts to STD clinics they allege don’t qualify

6 months ago

Viatris' India-based manufacturing site blocked from shipping 11 generic drugs to US

6 months ago

Sumitomo’s overactive bladder drug adds another indication

6 months ago

PDUFAs for Tonix and Nuvation; Sanofi vaccine partnership; RAPT allergy deal

6 months ago

FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market

6 months ago

Novo Nordisk’s once-daily hemophilia drug Alhemo approved in US

6 months ago

Vertex gets 'vanza triple' approval and Trikafta expansion — with boxed warnings

6 months ago

PBM reform unlikely to attach to short-term spending bill as shutdown looms

6 months ago

Accelerated approval brings Pfizer's BRAF inhibitor to first-line patients

6 months ago

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

FDA approves Humacyte’s lab-grown blood vessels in milestone for regenerative medicine

6 months ago

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