Home » Topics » Regulatory

Regulatory
RSS

Gensia receives ANDA approval for etoposide injection

May 21, 1997

Roche seeks FDA approval for new formulation of saquinavir

May 14, 1997

Bristol-Myers Squibb launches Vagistat-1 as OTC in the U.S.

May 13, 1997

RPR receives FDA clearance for new indication of enoxaparin

May 13, 1997

Update on Interferon Sciences' Alferon N Injection

May 13, 1997

Fujisawa's Prograf cleared by FDA for use in kidney transplantation

May 9, 1997

FDA approves Mylan's generic extended-release diltiazem

May 9, 1997

FDA clears generic antidepressant from Teva

May 7, 1997

ANDA filed for Biovail generic calcium channel blocker

May 7, 1997

Fosamax cleared as preventive medication in osteoporosis

May 7, 1997

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 15, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 12, 2025.
CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s trials
BioWorld
A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with...
Apollo’s APL-4098 shows potent antileukemic effects
BioWorld Science
Apollo Therapeutics Ltd. has developed APL-4098, a small-molecule general control nonderepressible 2 (GCN2) inhibitor for the potential treatment of AML.
FDA greenlights Medtronic Onyx subdural hematoma treatment
BioWorld MedTech
Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx...