Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2018
Amicus Therapeutics announces regulatory and clinical updates for AT-GAA in Pompe disease
10 September 2018 - Amicus Therapeutics announced today regulatory and clinical advancements in its development program AT-GAA for Pompe disease. ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 09 Sep 2018
GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients
7 September 2018 - GlaxoSmithKline today received a complete response letter from the US FDA regarding its application for mepolizumab ...
Posted by Michael Wonder on 07 Sep 2018
Tezepelumab granted breakthrough therapy designation by US FDA
7 September 2018 - AstraZeneca’s first breakthrough therapy designation for a respiratory medicine. ...
Posted by Michael Wonder on 07 Sep 2018
FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
7 September 2018 - Agency is taking additional steps to advance the development of new FDA approved treatments for opioid dependence ...
Posted by Michael Wonder on 07 Sep 2018
FDA approves Grifols new GamaSTAN (immunoglobulin [human]) to treat patients exposed to hepatitis A and measles
4 September 2018 - New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety ...
Posted by Michael Wonder on 07 Sep 2018
Fibrocell announces FDA fast track designation of FCX-013 for treatment of moderate to severe localised scleroderma
5 September 2018 - Fibrocell Science today announced that the U.S. FDA has granted fast track designation to FCX-013, the Company’s ...
Posted by Michael Wonder on 07 Sep 2018
Pfizer receives breakthrough therapy designation from FDA for PF-06651600, an oral JAK3 inhibitor, for the treatment of patients with alopecia areata
5 September 2018 - Phase II data accepted for late-breaker news session at 2018 EADV Congress. ...
Posted by Michael Wonder on 06 Sep 2018
Hospitals are fed up with drug companies, so they’re starting their own
6 September 2018 - A group of major American hospitals, battered by price spikes on old drugs and long-lasting shortages ...
Posted by Michael Wonder on 06 Sep 2018
ITF Pharma announces FDA approval of Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis
6 September 2018 - Tiglutik, the first and only easy-to-swallow thickened riluzole liquid for ALS, will be commercially available mid-October of ...
Posted by Michael Wonder on 06 Sep 2018
FDA extends review time for Roche’s Tecentriq/Avastin combination
6 September 2018 - US regulators have extended the review period for Roche’s application to market Tecentriq in combination with ...
Posted by Michael Wonder on 05 Sep 2018
The path to the first FDA approved cannabis-derived treatment and what comes next
5 September 2018 - Harvard neurologist Elizabeth Thiele is only half-kidding about the surprising direction her research has taken. ...
Posted by Michael Wonder on 05 Sep 2018
New program with payers aims to accelerate patient access to medical devices
5 September 2018 - Advancing the public health means helping to make sure patients have access to safe, effective medical products. ...
Posted by Michael Wonder on 05 Sep 2018
Statement from FDA Commissioner on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
5 September 2018 - Over the past 25 years, globalisation of drug manufacturing has prompted the FDA to change its ...
Posted by Michael Wonder on 05 Sep 2018
Loxo Oncology announces receipt of breakthrough therapy designation from U.S. FDA for LOXO-292
5 September 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a ...