Yearslong shortage of popular weight-loss and diabetes drugs resolved, FDA says
Shortages of Ozempic and Wegovy that have been in place for more than two years have been resolved, as supplies of obesity ...
Endocrinology Advisor1d
FDA Alert: Endocrinology Drug News Roundup 2025
FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...
The American Journal of Managed Care19h
5 Rare Diseases That Now Have Their First FDA-Approved Treatments
Several rare disease patient populations received their first-ever FDA-approved drug since Rare Disease Day last year, ...
BioSpace22h
6 Rare Diseases That Have New FDA-Approved Treatments
ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, ...
pulmonologyadvisor22h
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
Pharm Exec18h
FDA Approves Investigational New Drug Application for Fapon Biopharma’s Novel Immunotherapy for Solid Tumors
FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.
labiotech23h
Rare Disease Day: seven drugs awaiting approval in 2025
As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in ...
Pixel Watch 3 gets FDA approval to alert you if you’re dying
For example, the Pixel Watch, Apple Watch, and others can detect atrial fibrillation (AFib), a type of irregular heartbeat ...
Ozempic and Wegovy officially moved off FDA’s drug shortage list
Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed ...
BioPharma Dive4d
Mirum drug for rare genetic disease gains FDA approval
Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with ...
US FDA approves Mirum Pharma's genetic disorder drug
The U.S. Food and Drug Administration approved Mirum Pharmaceuticals' genetic disorder drug on Friday, making it the first ...
dvm3602d
First drug shown to reverse feline HCM expected to receive FDA conditional approval
Expanded conditional approval allows drugs that are undergoing their final clinical trial assessment and are supported by ...