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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Eylea (aflibercept) injection accepted for priority review by FDA for diabetic retinopathy in patients with diabetic macular oedema
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Bayer's Finacea (azelaic acid) 15% foam for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea
Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea (azelaic acid) 15% foam, for the topical ...
Posted by Michael Wonder on 05 Aug 2015
Drug companies pushed from far and wide to explain high prices
As complaints grow about exorbitant drug prices, pharmaceutical companies are coming under pressure to disclose the development costs and profits ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer
Genentech, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts Merck’s NDA for fixed-dose combination of raltegravir with lamivudine
Merck, known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a ...
Posted by Michael Wonder on 05 Aug 2015
Xadago (safinamide) new drug application accepted for filing by the U.S. Food and Drug Administration
Newron Pharmaceuticals S.p.A., a research and development company focused on novel central nervous system (CNS) and pain therapies, and its ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim’s new lung drug to cost $96,000
Boehringer Ingelheim GmbH priced its new treatment for a deadly lung-scarring disease at $96,000 a year, just higher than Roche ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants fast track designation to NKT Therapeutics' NKTT120 for the treatment of sickle cell disease
NKT Therapeutics today announced that the U.S. Food and Drug Administration has granted Fast Track designation to NKTT120, the company's ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves the Medicines Co's pain drug device Ionsys
The U.S. Food and Drug Administration approved the Medicines Co's drug device Ionsys for post-operative pain for hospital use, the ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi and Renegeron announce FDA approval of Praluent (alirocumab) injection, the first PCSK9 inhibitor in the U.S. for the treatment of high LDL cholesterol in adult patients
Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent (alirocumab) Injection, the first FDA-approved treatment ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Zomig (zolmitriptan) nasal spray for migraine in paediatric patients (ages 12-17)
Impax Specialty Pharma, a division of Impax Laboratories, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Zomig nasal spray for ...
Posted by Michael Wonder on 05 Aug 2015
Vertex submits applications in the U.S. and Europe for approval of lumacaftor in combination with ivacaftor for people with cystic fibrosis who have two copies of the F508del mutation
Vertex Pharmaceuticals Incorporated today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a ...
Posted by Michael Wonder on 05 Aug 2015
Takeda and Orexigen announce availability of Contrave (naltrexone HCl and bupropion HCl) extended-release tablets for chronic weight management in obese adults
Takeda Pharmaceutical Company Limited (“Takeda”), its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A., Inc. and Orexigen Therapeutics, Inc. (Nasdaq: OREX) jointly announced today ...
Posted by Michael Wonder on 05 Aug 2015
Actavis announces FDA approval of expanded label for Botox (onabotulinumtoxinA) for the treatment of upper limb spasticity in adults
Actavis plc (NYSE: ACT), which recently completed the acquisition of Allergan, today announced that the United States Food and Drug Administration (FDA) has ...
Posted by Michael Wonder on 05 Aug 2015
GSK receives FDA approval of an additional Promacta (eltrombopag) indication for use in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy
GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for ...