Home » Topics » Regulatory

Regulatory
RSS

Femara approved in Canada as first-line treatment for advanced breast cancer

May 24, 2001

FDA accepts for review Roche's sNDA for new Xenical indication

May 23, 2001

Effexor gains new FDA labeling approval regarding relapse

May 21, 2001

Statistically significant reductions in BP reported for enalapril/nitrendipine

May 21, 2001

Protonix I.V. now available in the U.S. for GERD

May 18, 2001

Rituximab filed in E.U., approved in U.S. for expanded indications

May 16, 2001

Oral therapy for CML developed at Novartis approved by FDA

May 14, 2001

CPMP issues approvable letter for use of desloratadine in CIU

May 11, 2001

New option for patients with refractory B-CLL will be available soon in U.S.

May 10, 2001

Novartis files for approval of Diovan for heart failure in several countries

May 4, 2001

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for July 10, 2026.
‘Target-high but uptake-defective’ state identified in ADC resistance
BioWorld
Separate research teams have reported new insights into resistance mechanisms to the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin, Astellas Pharma...
Hyperexcitability may be joint problem in epilepsy, dementia
BioWorld
The majority of epilepsies are developmental disorders that start in childhood. But there is a large minority that starts in late adulthood. And increasingly,...
Neurovalens granted FDA approval for PTSD therapy for US veterans
BioWorld
Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device,...
Ionis, AZ shares down on unexpected Wainua flop in cardiomyopathy
BioWorld
News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent...