Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2015
Teva announces FDA acceptance of the biologics license application for reslizumab
Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic Abilify to treat mental illnesses
The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical ...
Posted by Michael Wonder on 05 Aug 2015
Cost of cancer drugs should be part of treatment decisions
Treatment decisions are based on a hierarchy of factors. Drug effectiveness is considered to be the most important, followed by ...
Posted by Michael Wonder on 05 Aug 2015
Endo announces updated Xiaflex label with recurrence and retreatment data in patients with Dupuytren's contracture
Endo Pharmaceuticals Inc., a subsidiary of Endo International plc. today announced that the U.S. Food and Drug Administration (FDA) has approved a label update ...
Posted by Michael Wonder on 05 Aug 2015
Actavis receives FDA approval for Viberzi (eluxadoline) for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults
27 May 2015 - Actavis plc. announced today that Viberzi (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance of methylphenidate hydrochloride extended release chewable tablet NDA as ADHD treatment
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for methylphenidate hydrochloride ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants tentative approval for Lilly and Boehringer Ingelheim's Basaglar (insulin glargine injection)
The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve ...
Posted by Michael Wonder on 05 Aug 2015
VentiRx Pharmaceuticals announces fast track designation granted for motolimod (VTX-2337), a novel immunotherapy for women with ovarian cancer
VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits biologics license application for novel investigational LDL cholesterol-lowering medication evolocumab to the FDA
Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval ...
Posted by Michael Wonder on 05 Aug 2015
Summit Therapeutics receives FDA Fast Track Designation for novel antibiotic SMT19969 in the treatment of C. difficile infection
Summit Therapeutics plc, the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), announces that ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic Copaxone to treat multiple sclerosis
The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts Amgen's biologics license application for LDL cholesterol-lowering medication evolocumab
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
ARIAD’s AP26113 receives FDA breakthrough therapy designation for ALK+ non small-cell lung cancer resistant to crizotinib
Ariad Pharmaceuticals today announced that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the ...
Posted by Michael Wonder on 05 Aug 2015
FDA blueprint for helping children with rare diseases
The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare ...