Targeted Oncology3h
FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma
The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...
Healio3d
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 ...
emjreviews.com4h
EMA grants accelerated review to Gilead’s PrEP drug
The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...
Dallas Voice6d
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 ...
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 ...
Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia
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 for the treatment of ...
Morningstar10d
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 ...
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 ...