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Califf, on his way out at FDA, predicts agency tug-of-war between Ramaswamy and RFK Jr.

4 months ago

Rhythm receives expanded approval for genetic obesity drug

4 months ago

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

4 months ago

Applied Therapeutics CEO steps down after rare disease drug rejection

4 months ago

FDA approves Ionis’ treatment for a rare metabolic disorder

4 months ago

FDA rejects Zealand Pharma's short bowel syndrome drug

4 months ago

Xcovery nabs first FDA approval for lung cancer drug

4 months ago

Mesoblast wins long-awaited approval for cell therapy

4 months ago

Payers generally meet drug price watchdog's 'fair access' standards, report says

4 months ago

US spent $450B on drugs last year, CMS says, with new obesity and diabetes drugs adding to total

4 months ago

In surprise move, FDA's No. 2 Bumpus to leave agency at end of 2024

4 months ago

Pfizer’s message to investors: The ship is steadying in 2025 (even if Washington is turbulent)

4 months ago

AstraZeneca is denied full FDA approval of Andexxa following critical advisory meeting

4 months ago

HRSA pushes back against another 340B rebate model, this time from Sanofi

4 months ago

Neurocrine gets FDA go-ahead to treat rare adrenal gland condition

4 months ago

Checkpoint wins FDA approval of checkpoint inhibitor in advanced skin cancer, seeks partner for launch

4 months ago

Organon's steroid-free cream Vtama wins approval in atopic dermatitis

4 months ago

FDA stands by mifepristone safety label in federal court challenge

4 months ago

EMA's committee says expanded label for Lilly's Mounjaro into sleep apnea not necessary

4 months ago

Safety concerns and trial holds for pediatric RSV vaccines prompt caution from FDA adcomm

4 months ago

'Serious liver injury' cases lead FDA to call for monitoring of Ocaliva patients

4 months ago

During Covid, RFK Jr. lobbied against vaccine EUAs for children. As HHS secretary, he could rescind them

4 months ago

Drugs are approved — and made available — faster in US than most of EU, data show

4 months ago

The Endpoints 100: The biotech industry braces for Trump 2.0

4 months ago

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