JD Supra5d
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
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 ...
STAT8d
Biden administration moves to expand, preserve access to addiction treatments as term expires
In the face of an opioid overdose crisis, President Biden oversaw a historic shift toward harm reduction for addiction.
FDA Unveils Grounds For Rejecting Vanda Pharmaceuticals Stomach Paralysis Candidate
FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...
Nature24d
2024 FDA approvals
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 ...
Drug Store News24d
Hikma gets FDA nod for generic Victoza, launches 2 new generics
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 ...
NewsNation27d
Weight loss drug Zepbound approved to help sleep apnea patients
“This is a major step forward for patients with obstructive sleep apnea,” Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation ...