Wellbeing Whisper on MSN

FDA recall of blood pressure drug: What patients must know

More than 11,000 bottles of a widely prescribed blood pressure medication have been pulled from pharmacy shelves nationwide ...

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.
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 ...

Popular Cheese Recalled Nationwide Over Listeria Concerns, FDA Reports

Here’s a list of affected products.
FiercePharma

GSK's Tesaro, AnaptysBio lock horns in court over Jemperli agreement

Some four years into Jemperli’s commercial life span, a rift has emerged between GSK subsidiary Tesaro and the potential cancer blockbuster’s original developer, AnaptysBio. Tesaro has filed a lawsuit ...
Targeted Oncology

FDA Grants Full Approval to Tarlatamab in Small Cell Lung Cancer

Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...
Targeted Oncology

FDA Approves Sevabertinib in HER2-Mutated Nonsquamous NSCLC

Sevabertinib received accelerated FDA approval for HER2 TKD-mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO-01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as ...
The Business Journals

Gene therapy invented at Children's gets strongest FDA label after patient deaths

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...
Federal Register

Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...
The Business Journals

Sarepta Duchenne gene therapy gets strongest FDA label after patient deaths

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the ...