List view / Grid view
9 April 2014 | By Johnson & Johnson
Janssen Research & Development, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ study in relapsed or…
8 April 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announced that the U.S. Food and Drug Administration has approved Pradaxa® (dabigatran etexilate) for the treatment of DVT and PE...
3 April 2014 | By Penn Pharma
Pharmaceutical manufacturer Penn Pharma has announced an agreement with BioAlliance Pharma to manufacture one of their leading development products in Penn’s new contained manufacturing facility...
24 March 2014 | By Roche
Roche announced that the U.S. Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, a form of chronic hives...
20 March 2014 | By Pfizer Inc.
Pfizer intends to submit biologics license application for bivalent rLP2086 to U.S. Food and Drug Administration by mid-2014...
18 March 2014 | By Biogen Idec
Biogen Idec announced that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application for marketing approval of PLEGRIDY...
13 March 2014 | By Roche
Roche announced that the U.S. Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV Test...
3 March 2014 | By AstraZeneca
AstraZeneca announced that the US Food and Drug Administration has approved the BYDUREON® Pen 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes...
28 February 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Promacta™...
26 February 2014 | By AstraZeneca
AstraZeneca announced the FDA approved orphan drug MYALEPT™ , which is indicated as an adjunct to diet as replacement therapy for the treatment of complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy...
24 February 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has granted its investigational DCV Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection...
24 February 2014 | By Novartis
Novartis announced that its meningococcal serogroup B vaccine, Bexsero®, will be used as part of a vaccination program at the University of California Santa Barbara and will end on March 7...
20 February 2014 | By Merck
Merck announced that the Biologics License Application for V503...
19 February 2014 | By The European Medicines Agency
The European Medicines Agency and the United States Food and Drug AdministrationExternal link icon have set up a new 'cluster' on pharmacovigilance topics...
13 February 2014 | By Teva
24-month FDA post marketing commitment completed...
