The BMJ

Multiple sclerosis: Could Roche’s bestselling drug Ocrevus be doing more harm than good in women with primary progressive MS?

The US Food and Drug Administration (FDA) is reviewing a petition to revoke the approval of ocrelizumab for the treatment of ...
Healio

FDA approves Radiesse to treat chest wrinkles, despite breast imaging concerns

The FDA approved Radiesse for the treatment of wrinkles in the décolleté area for patients aged 22 years and older, despite ...
Clinical Advisor

FDA Approves Generic Dapagliflozin for Adults With T2D

Generic dapagliflozin is now approved for adults with type 2 diabetes, though current labeling excludes chronic kidney disease and pediatric use.
CT Insider on MSN

Recall of eye drops sold nationwide over sterilization concerns, FDA says

The recalled eye drop products include Best Choice, QC-Quality Choice, Sterile Eye drops Irritation Relief.
Seeking Alpha

Denali gains on FDA approval of lead asset (update)

Denali Therapeutics (DNLI) added ~9% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) approved its lead candidate, tividenofusp alfa, as a treatment for Hunter syndrome, ...
Fox Business

90,000 bottles of children's ibuprofen recalled nationwide, FDA says

Nearly 90,000 bottles of children’s ibuprofen have been recalled over the potential presence of a foreign substance, according to the Food and Drug Administration. Strides Pharma, Inc., headquartered ...
RAPS

FDA drafts guidance on animal testing alternatives

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...
USA Today

FDA: Novo Nordisk failed to report deaths of weight-loss drug patients

The manufacturer of popular weight-loss drugs Ozempic and Wegovy, Novo Nordisk, is taking heat from the federal government for regularly failing to report potential side effects of its GLP-1 ...
Wall Street Journal

How the FDA Kills a Drug

Donald Trump presses to pass the SAVE America Act, which would require proof of citizenship to register to vote, meaning many driver's licenses wouldn't be enough. As some Republicans demand a talking ...
Reuters

US FDA launches unified platform to report drug side effects

March 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform ‌designed to streamline the analysis of reports on drug side effects. Sign up here.
Scientific American

FDA declines to approve drug touted by Trump as a treatment for autism

The FDA on Tuesday approved leucovorin as a treatment for a rare genetic condition, not for autism, as the Trump administration had suggested The U.S. Food and Drug Administration on Tuesday approved ...
Bloomberg L.P.

US Senator Investigates FDA Over Rare-Disease Drug Denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s ...