FDA approves cochlear implants for children as young as 7 months

The U.S. Food and Drug Administration has approved an expanded indication for MED-EL (Medical Electronics) cochlear implants ...

Diaper Packages in N.Y. State Must Now Disclose All Ingredients

A first-of-its-kind law taking effect in December 2025 in New York state means more transparency around diaper ingredients ...

How to spot suspicious health supplements and avoid getting scammed

Snopes readers regularly ask whether supplement brands like Neurocept and Burn Peak are legit. Here's how you can tell yourself.
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 backdated for November 24 for Daiichi Sankyo’s tenosynovial giant cell ...
MedPage Today

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

The drugs are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV. The FDA ...
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 ...
Drug Store News

En-Vision America intros ScriptView Flip extended content prescription labels with RxCode

ScriptView Flip can be printed through ScriptAbility Software, which creates accessible prescription labels and features ...
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 ...