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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Actelion's new drug application for Selexipag (Uptravi) is accepted for review by the US FDA with a standard review time
Actelion Ltd. today announced the formal acceptance of the New Drug Application (NDA) for selexipag (Uptravi) by the US Food and ...
Posted by Michael Wonder on 05 Aug 2015
Clovis Oncology receives breakthrough therapy designation for rucaparib for monotherapy treatment of advanced ovarian cancer in patients with BRCA mutated tumours (inclusive of both germline and somatic BRCA mutations)
Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves expanded indication for Qudexy XR (topiramate) extended-release capsules within the paediatric population
Upsher-Smith announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for ...
Posted by Michael Wonder on 05 Aug 2015
Exelixis provides update on Genentech’s pending new drug application for cobimetinib, an Exelixis-discovered compound
Yesterday, Exelixis’ partner Genentech, a member of the Roche Group, informed Exelixis that, in order to accommodate its review of a supplemental data submission, ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts NDA for BI’s COPD combination
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants breakthrough therapy designation for Genzyme’s olipudase alfa
Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough therapy designation to ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Raplixa to help control bleeding during surgery
30 April 2015 - The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant ...
Posted by Michael Wonder on 05 Aug 2015
ALS patients press FDA for quick access to controversial biotech drug
For people with amyotrophic lateral sclerosis, which attacks the body’s motor neurons and renders a person unable to move, swallow ...
Posted by Michael Wonder on 05 Aug 2015
Aimmune Therapeutics receives FDA breakthrough therapy designation for AR101
Aimmune Therapeutics, Inc., a privately held biopharmaceutical company developing desensitization treatments for food allergies, announced today that the U.S. Food ...
Posted by Michael Wonder on 05 Aug 2015
Repros announces acceptance for filing of NDA
Repros Therapeutics Inc. today announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal, ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces submission of Biologics License Application to the FDA for investigational Meningococcal B vaccine
Pfizer Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Eylea (aflibercept) injection receives FDA approval for macular oedema following retinal vein occlusion
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea (aflibercept) Injection for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants Amgen priority review for Kyprolis (carfilzomib) supplemental new drug application for the treatment of relapsed multiple myeloma
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection ...
Posted by Michael Wonder on 05 Aug 2015
Uceris (budesonide) 2mg rectal foam for the induction of remission of mild-to-moderate distal ulcerative colitis granted tentative approval by FDA
Salix Pharmaceuticals, Ltd. today announced that the FDA has granted tentative approval for Uceris (budesonide) rectal foam for the induction of remission ...
Posted by Michael Wonder on 05 Aug 2015
Novartis announces FDA approval for first IL-17A antagonist Cosentyx (secukinumab) for moderate-to-severe plaque psoriasis patients
Novartis today announced the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis ...