The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...
Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the company’s  “new drug applications” for lencapavir, a twice-yearly ...
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
In a Phase Ib trial, 71 percent of patients responded to zongertinib and lived a median six months before disease progression or death.
Shares of Axsome Therapeutics ( AXSM -0.40%) are flying higher on Monday. The company's stock is up 24.7% as of 1:10 p.m. ET, ...
The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the ...
has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September ...
Insmed's promising drug pipeline includes Brensocatib and Arikayce. See why INSM stock is a strong pick with multi-billion ...
Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...