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RSS FeedPosted by Michael Wonder on 15 Feb 2019
CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis
15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for ...
Posted by Michael Wonder on 15 Feb 2019
FDA advances new efforts to promote development of safe and effective regenerative medicine products
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
Posted by Michael Wonder on 15 Feb 2019
Statement from FDA Commissioner on new policy to improve access and foster price competition for drugs that face inadequate generic competition
15 February 2019 - In too many cases, branded drugs that are no longer protected by patents or other exclusivities ...
Posted by Michael Wonder on 15 Feb 2019
Role of big data for evaluation and supervision of medicines in the EU
15 February 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support ...
Posted by Michael Wonder on 15 Feb 2019
RDD Pharma receives fast track designation from FDA for RDD-0315 for treatment of faecal incontinence in spinal cord injury patients
14 February 2019 - RDD Pharma announced today that the U.S. FDA granted fast track status for RDD-0315 for the treatment ...
Posted by Michael Wonder on 15 Feb 2019
Sarepta announces FDA acceptance of golodirsen (SRP-4053) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 53
14 February 2019 - FDA grants priority review status. ...
Posted by Michael Wonder on 15 Feb 2019
Whether the TGA should publish that a prescription medicine is under evaluation
15 February 2019 - The TGA is seeking comments from interested parties on whether or not the TGA should in future ...
Posted by Michael Wonder on 15 Feb 2019
FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices
14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...
Posted by Michael Wonder on 14 Feb 2019
Motif Bio receives complete response letter from the FDA
14 February 2019 - Motif Bio announced today that the Company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 14 Feb 2019
New weight loss pill launched in Australia
14 February 2019 - A new medication to help fight obesity has been launched in Australia. ...
Posted by Michael Wonder on 14 Feb 2019
Eisai submits application in Europe seeking approval for Fycompa as treatment for paediatric patients with epilepsy
13 February 2019 - Eisai announced today that it has submitted an application to the EMA for its in-house discovered ...
Posted by Michael Wonder on 14 Feb 2019
Harmony Biosciences announces file acceptance of its new drug application for pitolisant
12 February 2019 - FDA grants priority review of the pitolisant new drug application. ...
Posted by Michael Wonder on 14 Feb 2019
DBV Technologies provides update on regulatory status of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age
13 February 2019 - Progress made to date to enable resubmission in Q3 2019. ...
Posted by Michael Wonder on 14 Feb 2019
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease
13 February 2019 - Egaten is the only drug approved in the US for the treatment of people with fascioliasis and ...
Posted by Michael Wonder on 13 Feb 2019
Statement from FDA Commissioner on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. ...