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RSS FeedPosted by Michael Wonder on 10 May 2017
New safety risks detected in one-third of FDA approved drugs
9 May 2017 - Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that ...
Posted by Michael Wonder on 09 May 2017
TherapeuticsMD receives complete response letter from FDA for TX-004HR new drug application
8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC. ...
Posted by Michael Wonder on 09 May 2017
Novartis receives FDA approval for first-of-its-kind Kisqali Femara co-pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer
8 May 2017 - Co-Pack allows patients ability to obtain Kisqali and Femara with a single co-pay. ...
Posted by Michael Wonder on 09 May 2017
FDA grants fast track designation to XyloCor Therapeutics lead candidate XC001
8 May 2017 - XyloCor Therapeutics announced that the U.S. FDA has granted fast track designation to its lead product candidate ...
Posted by Michael Wonder on 09 May 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for Alzheimer’s disease agitation
8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation ...
Posted by Michael Wonder on 08 May 2017
PTC Therapeutics' DMD drug Emflaza to cost $35,000 a year and launch within the coming weeks
8 May 2017 - PTC Therapeutics said early Monday that it plans to launch the Duchenne muscular dystrophy drug Emflaza at ...
Posted by Michael Wonder on 08 May 2017
The first ALS drug in 22 years is approved -- and it costs 4 times what it does in Japan
5 May 2017 - For the first time in 22 years, the FDA approved a new drug to treat amyotrophic ...
Posted by Michael Wonder on 08 May 2017
PDA/FDA Biosimilars Conference - 26-27 June 2017
3 May 2017 - The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval ...
Posted by Michael Wonder on 07 May 2017
Post-approval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
3 May 2017 - Between 2005 and 2012 the FDA approved 117 novel drugs for 123 indications on the basis of ...
Posted by Michael Wonder on 06 May 2017
FDA approves drug to treat ALS
5 May 2017 - The U.S. FDA today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred ...
Posted by Michael Wonder on 05 May 2017
Sangamo Therapeutics announces special regulatory designations from the FDA for three clinical programs
4 May 2017 - Fast track designation for SB-FIX in vivo genome editing treatment for haemophilia B. ...
Posted by Michael Wonder on 04 May 2017
Cancer drugs are getting better and dearer
4 May 2017 - AstraZeneca’s Imfinzi costs $180,000 for a year’s treatment. ...
Posted by Michael Wonder on 04 May 2017
FDA and NIH release final template for clinical trial protocols
2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...
Posted by Michael Wonder on 04 May 2017
The failure of solanezumab — How the FDA saved taxpayers billions
3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...
Posted by Michael Wonder on 03 May 2017
Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz (tofacitinib citrate) for the treatment of adult patients with active psoriatic arthritis
3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for ...