The companies in question, Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, are recalling seizure treatments, ...

(With off-label use, a drug that’s approved for certain conditions is prescribed for another purpose.) However, the drug is not approved by the Food and Drug Administration (FDA) for this purpose.

The Food and Drug Administration (FDA ... packaged in a 9-ounce flexible poly bag containing six rolls. The product label includes the branding for Jesse's Bakery, Inc., along with its Honolulu ...

The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies.

There is a 7-step application process. The label is awarded by the relevant national organisation (competent body) that checks your application. 0.15% of the annual sales value of the certified ...

In September, Akeso, a little-known Chinese biotech company founded nearly a decade ago shook up the biotech sector with its new lung cancer drug. Ivonescimab, the new drug, was found in a trial ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...

2006 Voluntarily at any time a Includes new drug applications, biological license applications, and efficacy supplements.

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...

Indivior PLC, a global leader in addiction treatment, announced that the US Food and Drug Administration (FDA) has approved label changes for Sublocade including a rapid initiation protocol and ...

“In accordance with this direction, FDA is delaying the effective date of the final rule ‘Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”’ (89 FR 106064), until ...