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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Eylea (aflibercept) injection receives FDA approval for the treatment of diabetic macular edema
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea (aflibercept) injection for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist® (gadobutrol) injection ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat) for the treatment of HIV-1 infection in adults
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) ...
Posted by Michael Wonder on 05 Aug 2015
Sirtex Medical shares surge on liver cancer trial results and strong sales
Stronger than anticipated results in treating liver cancer from a key clinical trial by cancer treatment specialist Sirtex helped the ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration accepts biologics licensing application for Opdivo (nivolumab) for the treatment of advanced squamous non-small cell lung cancer
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics ...
Posted by Michael Wonder on 05 Aug 2015
AcelRx provides regulatory update on Zalviso
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
Relypsa submits new drug application to U.S. FDA seeking approval for patiromer for oral suspension to treat hyperkalaemia
22 October 2014 - Relypsa, Inc., today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food ...
Posted by Michael Wonder on 05 Aug 2015
FDA rescinds 'breakthrough' status for Merck's hepatitis C drug
The U.S. Food and Drug Administration will rescind Merck’s “breakthrough designation” for an experimental hepatitis C treatment, the pharmaceutical giant said Wednesday. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves use of Eliquis to treat leg, lung clots
Bristol-Myers Squibb Co and Pfizer Inc on Thursday said U.S. regulators have approved an expanded use for their Eliquis blood clot preventer, to ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo (nivolumab) in the U.S. and the European Union
Bristol-Myers Squibb Company today announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union. ...
Posted by Michael Wonder on 05 Aug 2015
Adapt Pharma submits NDA to FDA for Narcan (naloxone) nasal spray
Adapt Pharma Limited has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Narcan (naloxone) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Baxter's HyQvia for treatment of adults with primary immunodeficiency
Baxter International Inc. and Halozyme Therapeutics, Inc., today announced that the United States Food and Drug Administration (FDA) approved Baxter's subcutaneous treatment ...
Posted by Michael Wonder on 05 Aug 2015
Actavis and Gedeon Richter announce FDA receipt of NDA resubmission for cariprazine
Actavis plc. and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves Invega Trinza, first and only four-times-a-year treatment for schizophrenia
There’s a new treatment option for schizophrenia – Invega Trinza (three-month paliperidone palmitate), the first and only schizophrenia medication to be ...
Posted by Michael Wonder on 05 Aug 2015
Novartis tries to get U.S. ban lifted on sale of Neupogen copycat
Novartis AG unit Sandoz asked a U.S. appeals court on Wednesday to lift a preliminary injunction barring it from selling ...