Pulmonology Advisor

Novel Low-Sodium Oxybate Formulation Under FDA Review

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for TRN-257, a controlled-release, low-sodium oxybate product, for the treatment of c ...

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 product, per the document, and they shouldn’t suggest that a biosimilar is ...

FDA approves expanded indication for Jaypirca

The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib), the first and only noncovalent Bruton tyrosine kinase (BTK) inhibitor for adults ...