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 FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...

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.

PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamineTORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

Most major sections of the new animal drug application for Laverdia-CA1 have been deemed complete by the FDA, bringing the ...

Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

A groundbreaking cannabinoid-based antimicrobial, Silvanex, fights drug-resistant infections with a synergy of silver, CBC and CBG.

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 ...

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 ...

Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. 3 Colijn JM, Liefers B ...

Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug development strategy with plans for multiple new candidates this year.