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RSS FeedPosted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...
Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
Posted by Michael Wonder on 17 Jan 2019
New drug application for insomnia disorder treatment lemborexant submitted in the United States
15 January 2019 - Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, ...
Posted by Michael Wonder on 17 Jan 2019
Acurx receives FDA fast track designation for ACX-362E for the treatment of C. difficile infection
16 January 2019 - Phase 1 clinical study underway - anticipated completion second quarter 2019. ...
Posted by Michael Wonder on 17 Jan 2019
Menlo Therapeutics’ serlopitant granted breakthrough therapy designation by FDA for the treatment of pruritus associated with prurigo nodularis
15 January 2019 - Menlo Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for serlopitant for the ...
Posted by Michael Wonder on 16 Jan 2019
The FDA has five weeks till money runs out for approving new drugs
16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...
Posted by Michael Wonder on 16 Jan 2019
FDA approves first generic version of Sabril to help treat seizures in adults and paediatric patients with epilepsy
16 January 2019 - The U.S. FDA approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex ...
Posted by Michael Wonder on 16 Jan 2019
Amneal announces approval of rivastigmine transdermal system
14 January 2019 - Amneal Pharmaceuticals today announced that it has received FDA approval for a generic version of Exelon Patch ...
Posted by Michael Wonder on 16 Jan 2019
Challenges of non-intention-to-treat analyses
15 January 2019 - Over the past 5 decades, the randomised clinical trial has become the gold standard for evaluation ...
Posted by Michael Wonder on 15 Jan 2019
Nabriva Therapeutics provides update on PDUFA date for intravenous Contepo
14 January 2019 - PDUFA action date now set for 30 April 2019. ...
Posted by Michael Wonder on 15 Jan 2019
BeiGene receives U.S. FDA breakthrough therapy designation for zanubrutinib in mantle cell lymphoma
14 January 2019 - BeiGene today announced that the U.S. FDA has granted breakthrough therapy designation for its investigational Bruton’s tyrosine ...
Posted by Michael Wonder on 15 Jan 2019
If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy
14 January 2019 - The government shutdown could soon jeopardise highly anticipated new drugs from Janssen, Sanofi, and Novartis for ...
Posted by Michael Wonder on 15 Jan 2019
How a 'regulatory dead zone' may be holding up copycat insulin
14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...
Posted by Michael Wonder on 15 Jan 2019
Statement from FDA Commissioner and Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
15 January 2019 - The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced ...
Posted by Michael Wonder on 15 Jan 2019
FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination
14 January 2019 - First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the ...