DEERFIELD, Ill.–(BUSINESS WIRE)–Aug 31, 2011 – Baxter
International Inc. announced today that the U.S. Food and Drug
Administration (FDA) has expanded the indication of Artiss [Fibrin
Sealant (Human)] to include adhering tissue flaps during…
TOKYO, Aug. 28, 2011 /PRNewswire/ –Astellas Pharma Inc. today announced the submission of a New
Drug Application and Market Authorisation Application for
mirabegron (generic name / code name: YM178) to the U.S. Food and
Drug Administration and…
Basel, August 29, 2011 – Novartis has received a Complete
Response letter from the US Food and Drug Administration (FDA) as
part of the US regulatory review for ACZ885 (canakinumab) in gouty
arthritis patients. In its letter, the FDA requested…
SYDNEY and BEDMINSTER, N.J., Aug. 25, 2011 /PRNewswire/ –
QRxPharma Limited announced today
submission of its New Drug Application (NDA) clinical data package
to the United States Food and Drug Administration (FDA) for MoxDuo
IR, an…
CONSHOHOCKEN, PA — (Marketwire) — August 30, 2011 — NuPathe
Inc. today announced that it has received a
Complete Response Letter (CRL) from the U.S. Food & Drug
Administration (FDA) regarding the New Drug Application (NDA) for
its migraine…
