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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Eisai submits marketing approval applications for anticancer agent lenvatinib simultaneously in Europe and US
Eisai Co., Ltd. announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and ...
Posted by Michael Wonder on 05 Aug 2015
FDA rejects Avanir's migraine drug-device
The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new indication for Bayer's Kogenate
The US FDA has approved a new indication for German drug major Bayer's Kogenate FS antihemophilic factor VIII (recombinant), for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Praluent to treat certain patients with high cholesterol
The U.S. Food and Drug Administration today approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Uceris (budesonide) 2 mg rectal foam for the induction of remission of mild-to-moderate distal ulcerative colitis
8 October 2014 - Salix Pharmaceuticals, Ltd. today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) ...
Posted by Michael Wonder on 05 Aug 2015
Janssen submits new drug application for Yondelis (trabectedin) to U.S. FDA for the treatment of patients with advanced soft tissue sarcoma
Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for Yondelis (trabectedin) to the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts supplemental new drug application for Jakafi (ruxolitinib) and priority review granted
Incyte Corporation today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) ...
Posted by Michael Wonder on 05 Aug 2015
Clovis Oncology initiates rolling NDA submission to the FDA for rolicetinib in the treatment of advanced EGFR-mutant non small-cell lung cancer
Clovis Oncology, Inc. announced today that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the U.S. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Eagle Pharmaceuticals’ Ryanodex for the treatment of malignant hyperthermia
Eagle Pharmaceuticals, Inc. today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable ...
Posted by Michael Wonder on 05 Aug 2015
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for injection in the treatment of upper limb spasticity in adults in the United States
Ipsen today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) ...
Posted by Michael Wonder on 05 Aug 2015
Pacira receives complete response letter from FDA for sNDA seeking approval of Exparel use in nerve block to provide post-surgical analgesia
Pacira Pharmaceuticals, Inc. today announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following a ...
Posted by Michael Wonder on 05 Aug 2015
Trimel receives FDA approval for Natesto nasal gel to treat men with low testosterone
Trimel Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT, the first ...
Posted by Michael Wonder on 05 Aug 2015
PTC Therapeutics begins rolling NDA submission to the FDA for Translarna to treat Duchenne muscular dystrophy
PTC Therapeutics, Inc. today announced that it has commenced a rolling submission of a New Drug Application (NDA) to the United States ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves new indication for the use of Xtandi (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer
Medivation, Inc. and Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of Xtandi (enzalutamide) ...
Posted by Michael Wonder on 05 Aug 2015
Actavis announces FDA acceptance of sNDA for Saphris (asenapine maleate) for the treatment of bipolar I disorder in paediatric patients
Actavis plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' Supplemental New Drug Application (sNDA) for Saphris (asenapine maleate) ...