FDA panel calls to loosen restrictions on testosterone replacement therapy

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.
pharmaphorum

Sarepta rises after FDA adds warning label to Elevidys

Shares in Sarepta reversed some of their recent declines after the FDA added a warning label to its Duchenne muscular dystrophy (DMD) gene therapy, ending a protracted period of uncertainty for the ...
Fierce Pharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...
MedPage Today on MSN

FDA Opens Safety Review of Injectable RSV Drugs Approved for Babies and Toddlers

Spokesman fpr RFK Jr. described the inquiry as a routine safety evaluation ...
Medical Marketing & Media

Two new Untitled Letters, multiple close-outs: Latest on FDA’s pharma ad crackdown

More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one ...
Gastroenterology Advisor

Linzess Approval Expanded to Include Pediatric IBS-C

The FDA has approved Linzess (linaclotide) for treatment of irritable bowel syndrome with constipation (IBS-C) in patients 7 years of age and older.