Blog
RSS FeedPosted 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
Vericel receives FDA fast track designation for ixmyelocel-T, an investigational product for the treatment of patients with advanced heart failure due to ischaemic dilated cardiomyopathy
21 February 2017 - Vericel Corporation today announced that the U.S. FDA has designated the investigation of ixmyelocel‑T for reduction ...
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
CEO under fire for $89,000 drug has a history of steep price hikes
14 February 2017 - Sanders, Cummings requested information on increases in 2014. ...
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 ...
Posted by Michael Wonder on 16 Feb 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar pegfilgrastim for review
16 February 2017 - Second successful BLA filing of the partnership in the U.S. ...
Posted by Michael Wonder on 15 Feb 2017
FDA approves new psoriasis drug
15 February 2017 - The U.S. FDA today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. ...
Posted by Michael Wonder on 15 Feb 2017
Pharma industry shuns Trump push for radical shift at FDA
15 February 2017 - U.S. President Donald Trump's vow to roll back government regulations at least 75% is causing anxiety ...
Posted by Michael Wonder on 15 Feb 2017
Generic and biosimilar manufacturers launch new brand & campaign to expand access to medicines
14 February 2017 - Education campaign reinforces generics reduce drug costs, drive savings. ...
Posted by Michael Wonder on 15 Feb 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for treatment resistant depression
14 February 2017 - Axsome Therapeutics has received fast track designation from the U.S. FDA for AXS-05 for treatment resistant depression. ...
Posted by Michael Wonder on 15 Feb 2017
Former FDA Chief cites 5 things to watch on drug approvals and keeping drugs safe
14 February 2017 - The just-departed commissioner of the FDA has concerns about plans to speed up drug approvals and ...