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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA accepts Biologics License Application for Zinbryta (daclizumab high-yield process) for treatment of MS
Today Biogen and AbbVie announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new antifungal drug Cresemba
The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants Genentech’s Avastin priority review for certain types of cervical cancer
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the ...
Posted by Michael Wonder on 05 Aug 2015
Symplmed announces FDA approval of Prestalia for treatment of hypertension
Symplmed Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia (perindopril arginine and amlodipine) tablets, licensed ...
Posted by Michael Wonder on 05 Aug 2015
GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma
GlaxoSmithKline plc and Theravance, Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves a second vaccine to prevent serogroup B meningococcal disease
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis ...
Posted by Michael Wonder on 05 Aug 2015
Iroko Pharmaceuticals gains FDA approval of Zorvolex for management of osteoarthritis pain
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States ...
Posted by Michael Wonder on 05 Aug 2015
Heat Biologics, Inc. receives US FDA fast track designation for HS-410 (vesigenurtacel L) in combination with BCG for the treatment of non-muscle invasive bladder cancer
Heat Biologics, Inc., a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that the U.S. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first tissue adhesive for internal use
The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use. ...
Posted by Michael Wonder on 05 Aug 2015
Orexigen shares tumble as FDA delays weight-loss drug approval
Orexigen Therapeutics Inc. said the U.S. Food and Drug Administration has extended its review of the company's investigational weight-loss treatment, delaying regulatory ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Opdivo for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot ...
Posted 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, ...