The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.

Eight months after it was approved for sale in India, anti-diabetic drug Mounjaro is India’s highest-selling drug, even beating the antibiotic Augmentin, and it’s not because diabetes has spiked ...

USAntibiotics, the country's only domestic manufacturer of amoxicillin (Amoxil®) and amoxicillin clavulanate (Augmentin®), announced today that the U.S. Food and Drug Administration (FDA) has approved ...

The first CNPV approval falls into the latter category, and is for a US-manufactured version of the widely used antibiotic Augmentin XR (amoxicillin-clavulanate potassium) that was among the first ...

Penicillin G and 6-APA are key starting materials used in the production of several penicillin-based antibiotics, including ...

Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed timelines. Sponsors must execute market access, pricing, and post-approval ...

The FDA has awarded its latest national priority voucher to Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with daratumumab for the treatment of relapsed or refractory multiple myeloma ...

Illegible prescriptions may soon be a thing of the past. The National Medical Commission has ordered doctors to write ...

The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered a mop-up of all Europharm Laboratories products ...

The Indian judiciary did well not to let Novo Nordisk extend its exclusive right to sell semaglutide, marketed as Ozempic and ...