FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

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

The FDA approved the investigational new drug application for a phase 1 trial of ADCE-T02 in advanced solid tumors.

Mirum Pharmaceuticals’ Ctexli (chenodiol) has gained US Food and Drug Administration (FDA) approval for treating adults with ...

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

today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid ...

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

This new RXE is the second to receive acceptance by the FDA for a longevity drug developed by Loyal. The first, LOY-001, ...

The U.S. Food and Drug Administration (FDA) has approved Fapon Biopharma’s Investigational New Drug (IND) application for ...

This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic ...

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

The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...