Blog
RSS FeedPosted 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
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 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 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
FDA’s Pazdur and Blumenthal: the march of checkpoint inhibitors will continue
21 February 2017 - More approvals of new immune-checkpoint inhibitors, targeted and personalised therapies, as well as the use of ...
Posted by Michael Wonder on 22 Feb 2017
Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the U.S. FDA
21 February 2017 - Application requests approval for the treatment of relapsed or refractory acute lymphoblastic leukaemia in adults. ...
Posted by Michael Wonder on 21 Feb 2017
The Medicines Company announces FDA filing acceptance of new drug application for intravenous antibiotic Carbavance (meropenem-vaborbactam)
21 February 2017 - The Medicines Company today announced that the U.S. FDA has accepted for priority review the Company’s ...
Posted by Michael Wonder on 21 Feb 2017
Amphastar announces the receipt of a complete response letter for intranasal naloxone for the emergency treatment of opioid overdose
21 February 2017 - Amphastar Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for its new ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
Posted by Michael Wonder on 17 Feb 2017
FDA expands approval of Spriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children
16 February 2017 - Supplemental new drug application approved under priority review from the FDA. ...
Posted by Michael Wonder on 16 Feb 2017
Why drug companies don’t want President Trump to deregulate the FDA
16 February 2017 - When President Donald Trump met with big pharma CEOs at the White House last month, he ...