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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Pfizer receives US FDA breakthrough therapy designation for Xalkori (crizotinib) for the treatment of patients with ROS1 positive non small-cell lung cancer
Pfizer Inc. announced today that Xalkori (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Gazyva (obinutuzumab) supplemental biologics license application with new data in previously untreated chronic lymphocytic leukaemia
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer and Protalix BioTherapeutics announce FDA approval of pediatric indication for Elelyso (taliglucerase alfa) for injection, for intravenous use for the treatment of Type 1 Gaucher disease
Pfizer Inc. and Protalix BioTherapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for injection for ...
Posted by Michael Wonder on 05 Aug 2015
US ophthalmologists plead with drug regulator not to restrict access to Avastin
Ophthalmologists in the United States have criticized the Food and Drug Administration for issuing guidance that would potentially restrict the ...
Posted by Michael Wonder on 05 Aug 2015
Bellafil receives FDA approval for treatment of acne scars
Suneva Medical, Inc., a privately-held aesthetics company, announced today that the U.S. Food and Drug Administration (FDA) has approved the ...
Posted 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 ...