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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Auxilium Pharmaceuticals Inc announces Xiaflex now approved for the concurrent treatment of up to two affected joints in the same hand in Dupuytren's contracture patients
Auxilium Pharmaceuticals, Inc, a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics ...
Posted by Michael Wonder on 05 Aug 2015
Valeant and Progenics announce the submission of U.S. new drug application for oral Resistor
Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. today announced that Valeant submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration approves Kalydeco (ivacaftor) for use in people with cystic fibrosis ages 6 and older who have the R117H mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use ...
Posted by Michael Wonder on 05 Aug 2015
Mallinckrodt Pharmaceuticals’ New Drug Application accepted for review by FDA
Mallinckrodt plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-155. MNK-155 ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic esomeprazole
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat ...
Posted by Michael Wonder on 05 Aug 2015
Kythera Biopharmaceuticals announces FDA approval of Kybella (also known as ATX-101) — first and only submental contouring injectable drug
Kythera Biopharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Kybella, also known as ATX-101, “for improvement in ...
Posted by Michael Wonder on 05 Aug 2015
Avedro announces receipt of complete response letter from FDA for corneal cross-linking NDA
Avedro, Inc. announces that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the ...
Posted by Michael Wonder on 05 Aug 2015
Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA
Novartis announced today positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA grants priority review to AbbVie for investigational, all-oral, interferon-free therapy for the treatment of genotype 1 chronic hepatitis C
AbbVie announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Dalvance to treat skin infections
The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Rapamune to treat LAM, a very rare lung disease
The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new extended-release oxycodone with abuse-deterrent properties
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi and Regeneron announce that dupilumab has received FDA breakthrough therapy designation in atopic dermatitis
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Entyvio to treat ulcerative colitis and Crohn's disease
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative ...
Posted by Michael Wonder on 05 Aug 2015
Keryx Biopharmaceuticals receives FDA approval of ferric citrate, a new, oral iron-based treatment for dialysis patients with hyperphosphataemia
Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Ferric citrate (formerly known as Zerenex) for the control ...