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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Genzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
New drug application for Iressa accepted by US Food and Drug Administration
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves the labeling update of Abilify Maintena (aripiprazole) for extended-release injectable suspension to describe new clinical data for the treatment of acutely relapsed adults with schizophrenia
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration approved the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves use of Menactra vaccine for booster immunization against potentially deadly disease
Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) approved use of ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Aloxi (palonosetron hydrochloride) to prevent nausea and vomiting due to chemotherapy in children as young as 1 month
Eisai Inc. and Helsinn Group today announced the Food and Drug Administration (FDA) approval of Aloxi (palonosetron hydrochloride) injection for the ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves Eisai's anti-epileptic agent Fycompa as adjunctive treatment for primary generalised tonic-clonic seizures
Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
Celltrion seeks FDA approval for biosimilar Remsima
Celltrion Inc., which sells a cheap version of a top-selling rheumatoid arthritis drug in Europe, is now setting its sights on the ...
Posted by Michael Wonder on 05 Aug 2015
Richter and Allergan announce FDA has extended the review period for cariprazine to September 2015
Gedeon Richter Plc and Allergan Plc today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it ...
Posted by Michael Wonder on 05 Aug 2015
ViiV Healthcare receives FDA approval for Triumeq
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq (abacavir 600 mg, dolutegravir 50 mg ...
Posted by Michael Wonder on 05 Aug 2015
QRxPharma receives complete response letter from FDA regarding Moxduo NDA
QRxPharma Limited announced today the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the ...
Posted by Michael Wonder on 05 Aug 2015
TWi Pharmaceuticals receives US FDA final approval on generic megestrol acetate 125mg/mL oral suspension
TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Horizon Pharma plc receives FDA fast track designation for Actimmune in the treatment of Friedreich's ataxia
10 April 2015 - Horizon Pharma plc, a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and ...
Posted by Michael Wonder on 05 Aug 2015
Amarin Corporation announces ANCHOR complete response letter from FDA on Vascepa
Amarin Corp plc. announced the receipt of the anticipated complete response letter from the U.S. Food and Drug Administration (FDA) regarding its ...
Posted by Michael Wonder on 05 Aug 2015
Ipsen’s Somatuline Depot is the first therapy approved by the FDA in the United States for the treatment of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors
Ipsen today announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with ...