Below we have listed our top picks and condensed everything you need to know into a short review of each ... and custom document templates. Once you move up to the paid plans, your integrated ...
Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations ... While sunvozertinib is being studied as a second line or later treatment in the WU-KONG 1 Part B trial, ...
A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...
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 ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor ...
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 ...
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around ...
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review ... Therapeutics for an upfront payment of $1.05bn in 2019. In August 2021, the drug ...
Johnson & Johnson announced the nipocalimab Biologics License Application received Priority Review designation from the U.S Food and Drug Administration for the treatment of antibody positive ...
The White House’s Office of Management and Budget sent this document to government agencies listing about 2,600 programs that were under review.
The BLA submission is based on the primary analysis data of the IGNYTE trial, which evaluated RP1 in combination with nivolumab in patients with advanced melanoma who had not responded to anti-PD-1 ...