Blog
RSS FeedPosted by Michael Wonder on 09 Mar 2017
Few people actually benefit from ‘breakthrough’ cancer immunotherapy
8 March 2017 - People with cancer face many challenges, including the symptoms of the disease, the toxicity of the ...
Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase ...
Posted by Michael Wonder on 09 Mar 2017
PTC Therapeutics announces FDA acknowledgment of new drug application filing for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
6 March 2017 - FDA has assigned a PDUFA date of 24 October 2017. ...
Posted by Michael Wonder on 08 Mar 2017
FDA accepts supplemental new drug application for Vraylar (cariprazine)
8 March 2017 - Application seeks to expand Vraylar label to include phase 3 clinical data for the maintenance treatment ...
Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin. ...
Posted by Michael Wonder on 03 Mar 2017
Trump calls the FDA ‘slow and burdensome,’ but it’s faster than ever
2 March 2017 - Two days before Christmas, the Food and Drug Administration gave Thomas Crawford an unexpected gift: approval ...
Posted by Michael Wonder on 03 Mar 2017
FDA approves first treatment for frequent urination at night due to overproduction of urine
3 March 2017 - The U.S. FDA today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two ...
Posted by Michael Wonder on 03 Mar 2017
Trump vows to 'slash restraints' on drug development for FDA
1 March 2017 - President Donald Trump used his first address to a joint session of Congress on Tuesday to, ...
Posted by Michael Wonder on 02 Mar 2017
ALK announces FDA approval for its house dust mite sublingual allergy immunotherapy tablet (Acarizax in Europe)
1 March 2017 - ALK today announced that the US FDA has approved the biologics license application for its house ...
Posted by Michael Wonder on 02 Mar 2017
European and US regulators agree on mutual recognition of inspections of medicines manufacturers
2 March 2017 - Transatlantic agreement will help to make better use of inspection capacity and reduce duplication ...
Posted by Michael Wonder on 02 Mar 2017
FDA accepts new drug application and grants priority review for enasidenib in relapsed or refractory AML with an IDH2 mutation
1 March 2017 - PDUFA date set for 30 August 2017. ...
Posted by Michael Wonder on 02 Mar 2017
'Burdensome' FDA drug approval process fuels innovation, saves lives
28 February 2017 - I watched two speeches today that shared a common drug topic but with opposing philosophies. ...
Posted 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 ...