Targeted Oncology2d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Hosted on MSN2d
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
Historic FDA approval marks first nonopioid breakthrough since Clinton era
The Food and Drug Administration announced Thursday its approval of suzetrigine, the first new painkiller greenlit by the ...
Senators warn FDA about Super Bowl commercial believed to mislead patients
A group of Senators has warned the FDA about an ad expected to air during Sunday’s big game that they believe misleads ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
US FDA approves AbbVie-Pfizer's treatment for intra-abdominal infections
AbbVie said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
FiercePharma4d
Supernus' 4th try proves the charm with long-awaited FDA approval for Parkinson's infusion pump Onapgo
Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. | The device is ...
JD Supra9d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...