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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA approves Genzyme’s Cerdelga (eliglustat) capsules
Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga (eliglustat) capsules, the only ...
Posted by Michael Wonder on 05 Aug 2015
United States first country to launch Saxenda
Novo Nordisk today announced that Saxenda (liraglutide 3 mg) is now available in the United States (US). Saxenda is the first glucagon-like ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), ...
Posted by Michael Wonder on 05 Aug 2015
LEO Pharma announced new Taclonex (calcipotriene and betamethasone dipropionate) topical suspension, 0.005%/0.064% indication for the treatment of scalp plaque psoriasis in paediatric patients aged 12-17
LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, today announced a new Taclonex (calcipotriene and betamethasone dipropionate) ...
Posted 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 ...