Targeted Oncology4d
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 MSN3d
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 ...
BioSpace5h
AbbVie Gets FDA Approval for New Antibiotic in the Face of Rising Resistance
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
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 ...
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 ...
JD Supra11d
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 ...
FiercePharma5d
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 ...
FiercePharma8h
AbbVie scores FDA nod for Pfizer-partnered antibiotic Emblaveo
Ten months after Pfizer scored approval in Europe for Emblaveo (aztreonam and avibactam) to treat complicated intra-abdominal infections (cIAIs), AbbVie has done the same in the U.S., ...