If the FDA does not mention any timeline, the company may roughly ... is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict ...

The FDA gave the drug combination priority review and set a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, meaning it aims to make a decision about the two novel drugs on or before ...

The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...

In May 2013, obinutuzumab received Breakthrough Therapy Designation from the FDA, which is designed to speed up the development and review of medicines that treat life-threatening diseases.

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025.

Please provide your email address to receive an email when new articles are posted on . The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain ...

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it ...

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on July 22, 2025. Shares of REPL were up 16.9% on Jan. 21 following the announcement of the news.