Home » Topics » Regulatory

Regulatory
RSS

Orphan Medical's Busulfex Injection granted priority review

Oct. 8, 1998

HER2 diagnostic test approved in U.S.; will help identify candidates for Herceptin therapy

Oct. 8, 1998

FDA committee recommends approval of Epivir-HBV

Oct. 7, 1998

FDA approves Serevent Diskus for maintenance treatment of pediatric asthma

Oct. 7, 1998

Italian marketing approval obtained for metoclopramide nasal spray

Oct. 5, 1998

FDA approves anthracycline with orphan drug status for carcinoma in situ of the bladder

Oct. 5, 1998

First MMP inhibitor cleared for marketing as adjunct in periodontitis

Oct. 2, 1998

A novel use described for the proton pump inhibitor pantoprazole

Sep. 30, 1998

Genentech's Herceptin given FDA approval

Sep. 28, 1998

Expanded approval requested for chemoprotective agent

Sep. 24, 1998

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 24, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 24, 2025.
Researchers discover how glioblastoma tumors dodge chemotherapy
BioWorld MedTech
Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...
Big pharma taps fast Asia innovation in search of next Keytruda
BioWorld
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab),...
HIV research is close to a cure but far from ending the pandemic
BioWorld
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their...