George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group) ...

Discovering effective drug combinations may now be easier thanks to a screening platform made public today by St. Jude ...

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

Immunome stock is on track to open at its highest levels in over 20 months, after the company reported positive topline ...

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 ...

Abivax receives a "Strong Buy" rating, driven by positive phase 3 ABTECT induction data for obefazimod in moderate-to-severe ...

"Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin ...