Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...

The US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial ...

The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...

This rising trend mirrors the evolution of the pharmaceutical industry in terms of investment and utilisation of novel ...

The U.S. Food and Drug Administration formally authorized Zyn nicotine pouches for sale after conducting an "extensive ...

The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).

The partners expect the FDA to complete its review process in the fourth quarter of 2025. Simponi was first approved in 2009 and treats a variety of inflammatory conditions including rheumatoid ...

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...

A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic ...