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RSS FeedPosted by Michael Wonder on 05 Aug 2015
U.S. FDA accepts Eisai's NDA for Banzel (rufinamide) as adjunctive treatment in paediatric patients with Lennox-Gastaut syndrome
Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New ...
Posted by Michael Wonder on 05 Aug 2015
Teva announces FDA approval of ProAir RespiClick
Teva Pharmaceutical Industries Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) inhalation powder, a breath-actuated, ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves dual-chamber syringe for Abilify Maintena (aripiprazole) extended-release injectable suspension for the treatment of schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has ...
Posted by Michael Wonder on 05 Aug 2015
New indication for Vimpat (lacosamide): UCB’s anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
1 September 2014 – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve the quality and safety of the medical products Americans use
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health ...
Posted by Michael Wonder on 05 Aug 2015
Amgen receives FDA breakthrough therapy designation for investigational BiTE antibody blinatumomab in acute lymphoblastic leukaemia
Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational bispecific T cell engager (BiTE) ...
Posted 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 ...