Johnson & Johnson’s sNDA for Akeega gets US FDA approval to treat patients with BRCA2-mutated mCSPC: Horsham, Pennsylvania Wednesday, December 17, 2025, 13:00 Hrs [IST] Johnson ...

The firm expects to begin the Phase I trial in HER2-positive breast and gastric cancers in the first half of 2026.

Aldeyra submitted the single successful trial to the FDA over the summer and the agency accepted the resubmitted NDA for ...

The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for Aldeyra’s New Drug Application (NDA) for reproxalap for the treatment of dry ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...

The firm will share updated data and new analyses from its Phase III trial with the agency, which issued a complete response ...

We found that one-third of pharmaceutical companies proactively released the launch price of their medications between 2022 and 2024, and another third released them reactively. Smaller public ...

And GSK announced Thursday that the FDA had approved its medication gepotidacin, with the brand name Blujepa, as oral tablets to treat urogenital gonorrhea in people, 12 and older who weigh at least ...

The U.S. Food and Drug Administration announced it is reviewing a proposal to allow bemotrizinol in sunscreens sold in the United States.

Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster ...

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...