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RSS FeedPosted by Michael Wonder on 25 Dec 2016
The FDA's Christmas breakthrough
23 December 2016 - The FDA has always had a tendency to announce big news late on Fridays. ...
Posted by Michael Wonder on 23 Dec 2016
FDA approves first drug for spinal muscular atrophy
23 December 2016 - The U.S. FDA today approved Spinraza (nusinersen), the first drug approved to treat children and adults with ...
Posted by Michael Wonder on 22 Dec 2016
TGA approves new lung cancer drug osimertinib for patients dealt cruel double blow
23 December 2016 - Elly Calabia doesn't talk about survival rates and life expectancy with her oncologist. ...
Posted by Michael Wonder on 22 Dec 2016
Richter withdraws marketing application for biosimilar drug
19 December 2016 - Hungarian pharmaceuticals firm Richter has withdrawn its marketing application for one of its biosimilar drugs from ...
Posted by Michael Wonder on 21 Dec 2016
UCB’s anti-epileptic drug Vimpat (lacosamide) approved as monotherapy by European Commission
20 December 2016 - European monotherapy indication broadens clinical application of Vimpat for people with epilepsy living with partial-onset seizures. ...
Posted by Michael Wonder on 21 Dec 2016
Astellas announces FDA fast track designation for ASP0892, DNA vaccine for mitigation of severe hypersensitivity reactions due to peanut allergy
20 December 2016 - Astellas and Immunomic Therapeutics today announced that the U.S. FDA has granted fast track designation for the ...
Posted by Michael Wonder on 20 Dec 2016
Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma
20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...
Posted by Michael Wonder on 20 Dec 2016
Novo Nordisk receives FDA approval of Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes
19 December 2016 - Novo Nordisk today announced that the U.S. FDA approved an expanded indication for Tresiba (insulin degludec injection ...
Posted by Michael Wonder on 20 Dec 2016
Pfizer receives approval in the European Union for Nimenrix (meningococcal group A, C, W-135 and Y conjugate vaccine) in infants six weeks of age and older
19 December 2016 - Pfizer announced today the European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, ...
Posted by Michael Wonder on 20 Dec 2016
FDA grants Conatus fast track designation for development of emricasan in NASH cirrhosis
3 February 2016 - Conatus Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the company's emricasan ...
Posted by Michael Wonder on 20 Dec 2016
Dynavax receives complete response letter from U.S. FDA for biologics license application for Heplisav-B
14 November 2016 - Dynavax Technologies today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Dec 2016
TGA approves new uses for Janssen's Imbruvica
20 December 2016 - The TGA has approved the use of ibrutinib for first-line use in patients with chronic lymphocytic ...
Posted by Michael Wonder on 20 Dec 2016
Celltrion’s biosimilar granted marketing approval recommendation in Europe
19 December 2016 - South Korea’s Celltrion Inc., the world’s first developer of a biosimilar version to treat rheumatoid arthritis, ...
Posted by Michael Wonder on 20 Dec 2016
Tonix Pharmaceuticals’ PTSD Phase 3 ready drug candidate, TNX-102 SL, granted breakthrough therapy designation by the FDA
19 December 2016 - Responding to AtEase study results in military-related PTSD population, FDA agrees to work closely with Tonix ...
Posted by Michael Wonder on 19 Dec 2016
FDA grants accelerated approval to new treatment for advanced ovarian cancer
19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...