Home » Topics » Regulatory

Regulatory
RSS

FDA approves ZymoGenetics' Recothrom commercialization

Jan. 18, 2008

FDA approves BioMarin therapy for PKU

Dec. 14, 2007

Fastic/Starsis receives approval for supplemental NDA in Japan

Nov. 15, 2007

Mitsubishi Tanabe receives Japanese approval for extended indication of Remicade

Nov. 15, 2007

E.U. approves Pegintron/Rebetol therapy for HCV patients failing interferon therapy

Nov. 15, 2007

FDA approves Abilify for adolescent patients aged 13-17 years with schizophrenia

Nov. 9, 2007

European Commission grants marketing authorization for Nexavar

Nov. 2, 2007

Medtronic's drug-eluting stent receives CE Mark

Oct. 24, 2007

Acute heart failure approved as new indication for Sigmart Injection in Japan

Oct. 24, 2007

Renvela receives FDA approval for dialysis patients

Oct. 23, 2007

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for Dec. 17, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 17, 2025.
Vitesse finesse pays off: DBV wins in peanut allergy phase III
BioWorld
DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S....
Harbour Biomed closes busy year with $1B+ BMS deal
BioWorld
Harbour Biomed has added another collaboration to its end-of-year dealmaking, this time with Bristol Myers Squibb Co. (BMS) to develop multispecific antibodies....
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...