US FDA sends warning letters to Walmart, Target for selling recalled baby formula

The FDA said four major retailers continued to sell baby formula linked to a nationwide outbreak of bacterial illness in ...

FDA OKs libido-boosting pill for 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 Daiichi Sankyo's therapy in combination with Roche's drug for the ...

FDA mulls strongest safety warning for COVID-19 vaccines

The U.S. Food and Drug Administration is considering adding the strongest safety warning available to COVID-19 vaccines, ...

US FDA grants priority voucher to J&J's blood cancer treatment

The U.S. Food and Drug Administration said on Monday it has granted a national priority voucher to Johnson & Johnson's ...

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

Shares of French pharmaceutical group Sanofi fell 4% on Monday after it flagged another delay to a U.S. regulatory decision ...

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.

Walmart, Target, Kroger failed to remove recalled baby formula linked to ‘potentially fatal’ illness: FDA

Walmart, Target, Kroger and Albertsons accused of continuing to sell “adulterated” infant formula linked to an outbreak that ...

Chaos At The FDA Benefits America’s Rivals—At The Expense Of America’s Patients

If the FDA ceases to be a predictable source of regulatory guidance, then China will gain a significant advantage in the race ...
PharmExec

FDA Approves Lerochol for Adults with Elevated LDL Cholesterol

FDA has announced the approval of LIB Therapeutics’ Lerochol (lerodalcibep-liga) for subcutaneous (SC) use as an adjunct to ...
Fierce Pharma

FDA ‘proactively’ awards J&J a national priority review voucher for multiple myeloma drug combo

The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority ...
Medscape

FDA Approves First-in-Class Drug for Generalized Myasthenia Gravis

The B-cell depleting therapy is indicated for adults with generalized myasthenia gravis and anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies.