Home » Topics » Regulatory

Regulatory
RSS

New label sought for Enbrel in early, active RA

July 16, 1999

Hoechst Marion Roussel files for new indication of Refludan in U.S. and E.U.

July 15, 1999

Nastech completes phase III testing of intranasal scopolamine

July 13, 1999

Allergan ciclosporin NDA up for review this month by advisory committee

July 12, 1999

FDA advisory committee to consider OTC status for Flexeril

July 9, 1999

Pediatric formulation of Viramune now available in the E.U.

July 9, 1999

Novo Nordisk seeks approval for liquid GH in the U.S.

July 5, 1999

TAP Holdings seeks approval of erectile dysfunction treatment

July 2, 1999

FDA approves new formulation of Abbott's Norvir

July 1, 1999

Alza's Doxil approved in U.S. for treatment of refractory ovarian cancer

July 1, 1999

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Nov. 8, 2024.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for November 8, 2024.
Sales balloon for GLP-1 drugs from Novo Nordisk, Eli Lilly
BioWorld
Nearly $3.8 billion was earned by Novo Nordisk A/S and Eli Lilly and Co. in the third quarter for their glucagon-like peptide-1 (GLP-1) drugs to treat obesity....
Regulatory actions for Oct. 31, 2024
BioWorld
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capsida, Electra,...
Australia reimburses Vazkepa a decade after US approval
BioWorld
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug...

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.