Healio2d
FDA clears investigational new drug application for Zabalafin Hydrogel
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...
Dallas Voice5d
FDA accepts Gilead’s new drug applications for lencapavir
Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...
Why Axsome Therapeutics Stock Is Skyrocketing Today
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, ...
Healio6d
FDA accepts IND for allogenic CAR T-cell therapy that could bypass lymphodepletion
The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell ...
Business Wire6d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).
Science Daily2d
Novel method to synthesize valuable fluorinated drug compounds
Researchers have pioneered a new catalytic transformation that converts epoxides into fluorinated oxetanes, a coveted but difficult-to-make class of drug molecules that escaped synthetic preparation ...
Senores Pharma acquires US rights for COPD drug
The shares of Senores Pharmaceuticals Limited were trading at ₹570.70 up by ₹36.90 or 6.91% on the NSE today at 2.32 pm.
Business Wire5d
Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia
--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant ...
Morningstar9d
IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health
Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated: "We are delighted that the New Drug Application for Equecabtagene Autoleucel has been officially accepted by the Hong Kong ...