The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...

As multisite clinical research corporations (MCRCs) proliferate to meet the increased demand for larger clinical trials that ...

Gumokimab is the eighth successfully approved drug developed independently by Akeso (with six already approved for market), and it is also the third non-oncology innovative drug, following ebronucimab ...

The FDA urges manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses because ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...

Dr. Scott Manthei of the Nevada Ear and Sinus Institute has been advising patients against taking drugs like Sudafed for ...

Korea accelerates drug approvals by requiring 180-day advance supply suspension notice Korea reforms its drug approval ...

(The Center Square) – The U.S. Food and Drug Administration has revoked authorization for ... CSPI argued that the use of the ...

M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic drugs provide additional treatment options which are generally more affordable for ...