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RSS FeedPosted by Michael Wonder on 17 Oct 2017
Cognition Therapeutics receives fast track designation from U.S. FDA for first-in-class Alzheimer's candidate, CT1812
16 October 2017 - Cognition Therapeutics today announced that the U.S. FDA has granted fast track designation to its investigational ...
Posted by Michael Wonder on 16 Oct 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review
16 October 2017 - Application based on results from Phase 3 CheckMate-238 study. ...
Posted by Michael Wonder on 16 Oct 2017
The cost of developing drugs is insane. That paper that says otherwise is insanely bad.
16 October 2017 - You probably know this poem, or at least the story it tells. One man likens the ...
Posted by Michael Wonder on 16 Oct 2017
Exelixis announces U.S. FDA grants priority review for Cabometyx (cabozantinib) as a treatment for previously untreated advanced renal cell carcinoma
16 October 2017 - FDA assigns Prescription Drug User Fee Act action date of 15 February 2018. ...
Posted by Michael Wonder on 16 Oct 2017
Cancer drug study data was falsified, says AstraZeneca
14 October 2017 - An early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the ...
Posted by Michael Wonder on 16 Oct 2017
Where the FDA is going under Trump
15 October 2017 - Commissioner Scott Gottlieb says it isn’t about more or fewer regulations. It’s about efficiency. ...
Posted by Michael Wonder on 16 Oct 2017
FDA clears new robotically-assisted surgical device for adult patients
13 October 2017 - Today, the U.S. FDA cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can ...
Posted by Michael Wonder on 14 Oct 2017
Prometic announces FDA acceptance of its biologics license application for plasminogen (Ryplazim)
13 October 2017 - Ryplazim previously granted fast track, rare paediatric disease and orphan drug designations by U.S. FDA. ...
Posted by Michael Wonder on 14 Oct 2017
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate-to-severe plaque psoriasis
13 October 2017 - Findings from a registrational study showed Stelara led to significant skin clearance results at week 12. ...
Posted by Michael Wonder on 14 Oct 2017
Nearly one-third of new drugs are no better than older drugs, and some are worse
6 October 2017 - A focus on expediting drug development. ...
Posted by Michael Wonder on 13 Oct 2017
A ‘holy cow’ moment: the FDA approved a record number of generics
12 October 2017 - As the FDA attempts to foster more competition in the prescription drug market, the agency appears ...
Posted by Michael Wonder on 12 Oct 2017
AcelRx Pharmaceuticals receives complete response letter from the FDA for Dsuvia NDA
12 October 2017 - AcelRx Pharmaceuticals today announced that it received a complete response letter from the U.S FDA regarding its ...
Posted by Michael Wonder on 12 Oct 2017
FDA clears first 7T magnetic resonance imaging device
12 October 2017 - Today, the U.S. FDA cleared the first seven tesla (7T) magnetic resonance imaging device, more than ...
Posted by Michael Wonder on 12 Oct 2017
U.S. FDA approves Lyrica CR (pregabalin) extended-release tablets
12 October 2017 - New formulation may offer convenience to patients. ...
Posted by Michael Wonder on 12 Oct 2017
FDA grants priority review for potential new indication for Lilly's Verzenio (abemaciclib) as initial treatment of advanced breast cancer
12 October 2017 - Eli Lilly and Company today announced that the U.S. FDA has granted priority review designation for its ...