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RSS FeedPosted by Michael Wonder on 01 Mar 2017
FDA approves Odactra for house dust mite allergies
1 March 2017 - The U.S. FDA today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) ...
Posted by Michael Wonder on 01 Mar 2017
Trump derides ‘slow and burdensome’ approval process at FDA
28 February 2017 - President Trump on Tuesday called on the FDA to speed the approval of drugs to treat ...
Posted by Michael Wonder on 01 Mar 2017
Teva announces priority review granted by FDA for SD-809 for treatment of tardive dyskinesia
28 February 2017 - Teva Pharmaceutical Industries today announced the U.S. FDA has accepted the new drug application and granted ...
Posted by Michael Wonder on 01 Mar 2017
FDA accepts the biologics license application for avelumab for the treatment of metastatic urothelial carcinoma for priority review
28 February 2017 - Second biologics license application accepted by the FDA for avelumab. ...
Posted by Michael Wonder on 01 Mar 2017
Public-private partnership speeds investigator access to cancer drugs
28 February 2017 - A new collaboration between pharmaceutical and biotech companies and the National Cancer Institute at the National ...
Posted by Michael Wonder on 28 Feb 2017
OncoSec granted FDA fast track designation for ImmunoPulse IL-12 for the treatment of metastatic melanoma following progression on pembrolizumab or nivolumab
28 February 2017 - Provides opportunities for upcoming Phase 2b PISCES clinical trial and future clinical development. ...
Posted by Michael Wonder on 28 Feb 2017
FDA approves Xermelo for carcinoid syndrome diarrhoea
28 February 2017 - The U.S. FDA today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for ...
Posted by Michael Wonder on 28 Feb 2017
FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type 2 diabetes mellitus
28 February 2017 - Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to ...
Posted by Michael Wonder on 27 Feb 2017
2016: A record-setting year for generic drugs
24 February 2017 - Over the last 10 years, generic drugs have saved the U.S. health care system about $1.68 trillion. ...
Posted by Michael Wonder on 26 Feb 2017
FDA officials defend agency's flexibility under current regulatory framework
24 February 2017 - Top officials at the US FDA are defending the agency's flexibility to accelerate the availability of ...
Posted by Michael Wonder on 25 Feb 2017
Auris Medical receives FDA fast track designation for AM-111 in acute sensorineural hearing loss
24 February 2017 - Auris Medical today announced that the US FDA has granted fast track designation for AM-111 in ...
Posted by Michael Wonder on 24 Feb 2017
Tocagen receives breakthrough therapy designation from U.S. FDA for Toca 511 & Toca FC in recurrent high grade glioma
23 February 2017 - Tocagen today announced the U.S. FDA has granted Toca 511 & Toca FC breakthrough therapy designation for ...
Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ...
Posted by Michael Wonder on 23 Feb 2017
FDA expands indication for Revlimid (lenalidomide) as a maintenance treatment for patients with multiple myeloma following autologous haematopoietic stem cell transplant (auto-HSCT)
22 February 2017 - Approval enables Celgene to provide patients with treatment options across the multiple myeloma spectrum. ...
Posted by Michael Wonder on 22 Feb 2017
Lead cancer immunotherapy candidate receives FDA fast track designation
21 February 2017 - Cell Medica today announced the U.S. FDA has granted fast rrack designation to its lead oncology ...