CORRECTING AND REPLACING: FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor

In December 2025, pimicotinib was approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with symptomatic TGCT for which surgical resection will ...

Assessing Merck KGaA (XTRA:MRK) Valuation After FDA Pimicotinib Filing And Earnings Beat

Merck KGaA (XTRA:MRK) is back in focus after the U.S. FDA accepted its new drug application for pimicotinib, supported by ...
Nasdaq

Merck’s Biologics License Application for clesrovimab accepted by FDA

Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to protect ...
Nasdaq

Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease ...

If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known ...
Healio

FDA accepts biologics license application for Merck’s RSV shot

Please provide your email address to receive an email when new articles are posted on . Clesrovimab is a monoclonal antibody that protects against RSV subtypes A and B. The FDA set a PDUFA date for ...