FDA approves label change for Depo-Provera, adding brain tumor warning

Pfizer faces a lawsuit in which women allege the drugmaker failed to warn them about the risks of meningioma associated with the birth control shot.

FDA announces recall of frozen dessert pints over possible 'small stones'

The FDA announced a voluntary recall of non-dairy frozen dessert pints sold at stores nationwide over the potential presence of small stones.

Recalled formula is still on shelves. The FDA is warning retailers

The recalled formula, ByHeart Baby Formula, has been linked to 51 cases of confirmed or suspected infant botulism.

US FDA approves GSK's twice-yearly asthma drug

The U.S. health regulator has approved GSK's add-on drug to treat severe asthma, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.

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.

Kenvue Faces FDA Petition to Remove Benadryl’s Active Ingredient

Kenvue Inc. is dealing with another challenge to a top-selling product as it attempts to close its $40 billion acquisition by Kimberly-Clark Corp.

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.

GSK Says US FDA Approved Its Twice-Annual Asthma Drug Exdensur

GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.

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,
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that restricted the use of RWE in product applications, potentially accelerating treatment approvals.
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