FDA+ channel feed – Endpoints News

FDA+ channel feed

Invivyd requests emergency use authorization for Covid-19 preventive antibody among immunocompromised

Last year

FDA seizes thousands of counterfeit Ozempic units, warns consumers not to use

Last year

IRA likely to lead to higher drug list prices and bigger rebates, Congressional Budget Office predicts

Last year

Iovance’s registrational lung cancer trial on hold after patient death

Last year

FDA declines to grant Amgen’s Lumakras full approval in lung cancer after negative advisory committee vote

Last year

Following FDA inquiry into CAR-T safety, agency adds warning on secondary cancers for Carvykti

Last year

FDA approves AstraZeneca, Ionis' ATTR drug as showdown with Alnylam heats up

Last year

Calliditas wins full approval for steroid drug in rare autoimmune disease

Last year

Pharma companies delist patents from FDA's Orange Book following FTC challenges

Last year

FDA findings at Moderna's Massachusetts facility don't reflect quality, safety concerns, company says

Last year

FDA hands CRL to Merck's chronic cough drug over efficacy questions

Last year

FDA to set up new Office of the Chief Medical Officer as part of agency reshuffling

Last year

Genentech's food allergy medication gets priority review nod from the FDA

Last year

FDA encourages collaboration between monoclonal antibody sponsors to keep pace with emerging Covid variants

Last year

FDA approves Chiesi’s gel for rare skin disease after initial 2022 rejection for Amryt

Last year

Merck clinches priority review for pneumococcal vaccine, raising stakes for Pfizer

Last year

FDA broadens authorization for Akili's video game for ADHD

Last year

Arcutis scores FDA approval for new foam treatment for common skin condition

Last year

FDA finalizes opioid safety labeling changes

Last year

FDA rejects Checkpoint Therapeutics' PD-L1 drug cosibelimab over manufacturing issues

Last year

Merck's Welireg wins label expansion in kidney cancer despite missing survival data

Last year

FDA converts accelerated to full approval for Padcev-Keytruda combo in bladder cancer

Last year

Europe lines up first CRISPR therapy approval

Last year

Patent thicket strategy with terminal disclaimers helps block biologic competition, JAMA letter shows

Last year

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