FDA panel recommends testosterone therapy be more accessible to men, knocks ‘outdated’ restrictions

The narrow FDA labeling makes it so that only a minority of men who could benefit from treatment are considered ‘on-label’ ...

FDA approves updated label for Unloxcyt

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...

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 ...

Nasal spray sold nationwide recalled due to mold, ‘life-threatening' infections possible, FDA says

The voluntary recall of ReBoost Nasal Spray was issued Wednesday by MediNatura New Mexico, according to an announcement from ...
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 ...
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 ...

Prilenia and Ferrer Announce FDA Clearance to Start the "PREVAiLS" Pivotal Phase 3 Study with Pridopidine in ALS

In addition to ALS, pridopidine is in late-stage clinical development for HD, with Prilenia and Ferrer planning to initiate a confirmatory study in HD designed to confirm pridopidine's effects and ...
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 ...
Medscape

Medscape Medical News - FDA Approvals

Alert FDA Approves Third-Ever Drug for Lupus Nephritis Obinutuzumab (Gazyva) is the first drug to be approved for lupus nephritis since the approvals of belimumab (Benlysta) in 2020 and voclosporin ...