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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives amended U.S. FDA breakthrough therapy designation for investigational daclatasvir-based hepatitis C regimen
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer’s investigational vaccine candidate for Clostridium difficile receives U.S. Food and Drug Administration fast track designation
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium ...
Posted by Michael Wonder on 05 Aug 2015
Celgene bet $1 billion that this biotech's science can cure deadly cancers
Celgene is making a billion dollar bet on game-changing science. ...
Posted by Michael Wonder on 05 Aug 2015
Galderma receives FDA approval to market Restylane Lyft with lidocaine to correct age related volume loss in the cheek area
Galderma, a global healthcare company focused on skin health, announced today that it has received U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
Novo Nordisk receives FDA approval for Saxenda® for the treatment of obesity
Novo Nordisk today announced that the US Food and Drug Administration has approved the New Drug Application for Saxenda (liraglutide 3 mg), the ...
Posted by Michael Wonder on 05 Aug 2015
Valeant Pharmaceuticals announces FDA approval of Jublia for the treatment of onychomycosis
Valeant Pharmaceuticals International, Inc. today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food ...
Posted by Michael Wonder on 05 Aug 2015
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost ...
Posted by Michael Wonder on 05 Aug 2015
Novartis cell treatment named \"breakthrough therapy\" in US
Swiss drugmaker Novartis said on Monday U.S. health regulators have granted its personalised cell therapy CLT019 "Breakthrough Therapy" status, meaning ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism
The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients ...
Posted by Michael Wonder on 05 Aug 2015
AZ bags US nod for Xigduo XR
US regulators have approved AstraZeneca’s Xigduo XR, giving patients with diabetes type II access to the first once-daily pill combining ...
Posted by Michael Wonder on 05 Aug 2015
Actavis confirms complete response letter for nebivolol/valsartan fixed-dose combination for hypertension
Actavis plc today confirmed that the Company has received a complete response letter from the U.S. Food and Drug Administration for its New ...
Posted by Michael Wonder on 05 Aug 2015
Pomalyst (pomalidomide) label update including progression-free and overall survival benefits approved by U.S. FDA
Celgene Corporation today announced it has fulfilled the accelerated approval requirements for Pomalyst (pomalidomide) based on results from MM-003, an international phase III ...
Posted by Michael Wonder on 05 Aug 2015
Bill to speed drug development passes House despite opposition
The U.S. House of Representatives passed a bill to speed drug development and increase funding for medical research, surmounting reservations ...