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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Sarepta Therapeutics announces plans to submit rolling NDA for eteplirsen following today’s pre-NDA meeting with the FDA
Sarepta Therapeutics, Inc, a developer of innovative RNA-targeted therapeutics, today announced that the Company held a pre-New Drug Application (NDA) ...
Posted by Michael Wonder on 05 Aug 2015
Lilly's Cyramza (ramucirumab) in combination with paclitaxel granted FDA approval for advanced gastric cancer after prior chemotherapy
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Cyramza (ramucirumab) in combination with paclitaxel (a type ...
Posted by Michael Wonder on 05 Aug 2015
Novartis' heart failure medicine LCZ696 granted FDA priority review
Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review designation to LCZ696, an investigational ...
Posted by Michael Wonder on 05 Aug 2015
FDA panel turns down fast-track approval of AstraZeneca cancer drug
AstraZeneca failed to win accelerated approval of a cancer drug in the U.S., dealing a blow to its new drug-development pipeline, ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new use for Celgene's cancer drug Revlimid
The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp's cancer drug Revlimid to include newly ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Daklinza (daclatasvir) for the treatment of patients with chronic hepatitis C genotype 3
Bristol-Myers Squibb Company announced today that Daklinza (daclatasvir), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
Ipsen submits marketing authorization applications in the US and Europe for Somatuline Autogel (lanreotide acetate) in the treatment of gastroenteropancreatic neuroendocrine tumours
Ipsen today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration for Somatuline Autogel (lanreotide ...
Posted by Michael Wonder on 05 Aug 2015
Valeant Pharmaceuticals announces FDA approval of Onexton gel for the treatment of acne vulgaris
Valeant Pharmaceuticals International, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) for Onexton gel (clindamycin phosphate and ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts BLA filing for Synageva's Kanuma (sebelipase alfa); grants priority
Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, announced today that the U.S. Food and Drug Administration (FDA) ...
Posted 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 ...