FDA commissioner on growing public mistrust of government health advice

FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health guidance.
Fierce Pharma

Novo gets FDA warning letter at troubled Indiana site formerly owned by Catalent

Novo Nordisk, which has stumbled through a bit of a manufacturing hangover at a former Catalent production site it

FDA says it may relax warning label rule for dietary supplements

Supplements aren’t reviewed for safety and effectiveness, but disclaimers about health benefits are required on products.

FDA OKs libido-boosting pill for older women who have gone through menopause

U.S. health officials have expanded approval of a drug that boosts libido in women who report stress due to a low sex drive.

AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment

The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer,

FDA approves first at-home device for depression. What is it?

The FDA has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants.
Healthline

FDA Says It's Time to Ease Restrictions on Testosterone Replacement Therapy

An FDA panel of experts has called for a loosening of regulations and expanding access to testosterone replacement therapy.

Sanofi flags second delay to FDA decision on multiple sclerosis drug, shares fall

French drugmaker Sanofi on Monday flagged another delay to a U.S. regulatory decision for its experimental multiple sclerosis drug and reported disappointing results from a late-stage study, sending shares of the company down 2%.
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