The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...

The Food and Drug Administration (FDA) has accepted under Priority Review the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, for the prevention of HIV as ...

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 ...

Zabalafin Hydrogel is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic (anti-itch ...

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).

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 ...

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 ...

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.

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 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 ...