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RSS FeedPosted by Michael Wonder on 19 Oct 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...
Posted by Michael Wonder on 18 Oct 2017
US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review
18 October 2017 - Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer. ...
Posted by Michael Wonder on 18 Oct 2017
Radius Health receives FDA fast track designation for elacestrant (RAD1901)
18 October 2017 - Radius plans to initiate Phase 2 clinical study of elacestrant as a third-line therapy for women with ...
Posted by Michael Wonder on 17 Oct 2017
Generic drug user fees reauthorisation: a victory for public health
17 October 2017 - We marked an important milestone in the U.S. generic drug program on 1 October 2017 – the ...
Posted by Michael Wonder on 17 Oct 2017
US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small-cell lung cancer
17 October 2017 - Acceptance follows FDA’s breakthrough therapy designation. ...
Posted 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. ...