Blog
RSS FeedPosted by Michael Wonder on 22 Apr 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
21 April 2017 - First positive CHMP opinion for an immuno-oncology agent for patients with locally advanced or metastatic urothelial cancer. ...
Posted by Michael Wonder on 20 Apr 2017
Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment
19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of ...
Posted by Michael Wonder on 19 Apr 2017
Health Canada approves Tecentriq (atezolizumab) for patients with locally advanced and metastatic bladder cancer
18 April 2017 - Early data suggests Tecentriq shows strong efficacy for metastatic bladder cancer patients, offering the first new ...
Posted by Michael Wonder on 18 Apr 2017
FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer
18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...
Posted by Michael Wonder on 18 Apr 2017
Submissions received and TGA response: orphan drug program
18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 18 Apr 2017
Janssen receives Health Canada approval of Darzalex (daratumumab) by priority review for patients with multiple myeloma who have had at least one prior therapy
17 April 2017 - Darzalex combination therapy significantly improved progression-free survival compared to standard of care regimens alone. ...
Posted by Michael Wonder on 18 Apr 2017
FDA approves Genentech’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States
17 April 2017 - Granted priority review designation by the FDA based on analysis of results from a National Institutes of ...
Posted by Michael Wonder on 14 Apr 2017
U.S. FDA issues complete response letter for baricitinib
14 April 2017 - Eli Lilly and Incyte Corporation announced today that the U.S. FDA has issued a complete response ...
Posted by Michael Wonder on 14 Apr 2017
Fast start for FDA drug approvals in 2017
12 April 2017 - The US FDA is poised to make a comeback from the relatively low number of new ...
Posted by Michael Wonder on 11 Apr 2017
FDA approves first drug to treat tardive dyskinesia
11 April 2017 - The U.S. FDA today approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the ...
Posted by Michael Wonder on 07 Apr 2017
Merck receives complete response letter from the U.S. FDA for TECOS study with sitagliptin
7 April 2017 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental new ...
Posted by Michael Wonder on 07 Apr 2017
FDA approves two hepatitis C drugs for paediatric patients
7 April 2017 - The U.S. FDA today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to ...
Posted by Michael Wonder on 06 Apr 2017
Regulatory review of new therapeutic agents — FDA versus EMA (2011–2015)
6 April 2017 - The FDA faces continual pressure to accelerate the regulatory review and approval of new medicines. ...
Posted by Michael Wonder on 06 Apr 2017
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
6 April 2017 - The U.S. FDA today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for ...
Posted by Michael Wonder on 04 Apr 2017
AB2 Bio’s tadekinig alfa therapy receives breakthrough therapy designation from the US FDA for the treatment of monogenic, interleukin-18 associated auto-inflammatory conditions with ongoing systemic inflammation
3 April 2017 - Breakthrough therapy designation recognises the major potential therapeutic benefits of tadekinig alfa in the treatment of ...