The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with multibillion-dollar potential, according to internal documents seen by Reuters.

The FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for people with severe asthma.

Insider.comNews Commentary – The FDA is moving to require just one clinical trial for new drug approvals, signaling a dramatic shift toward faster regulatory pathways that could accelerate oncology ...

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 ...

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 ...

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 ...