The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients ...

Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

Artificial intelligence improves process control and reduces the time required to produce key products such as the COVID-19 ...

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

The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...

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).

Porosome Therapeutics, Inc. announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).

The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...

Gireesh Babu, New Delhi Thursday, February 27, 2025, 08:00 Hrs [IST] ...

UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...