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RSS FeedPosted by Michael Wonder on 20 Jun 2018
Alexion submits application for priority review and approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the U.S.
19 June 2018 - Submission in the European Union on track for mid-year and in Japan for the second half of ...
Posted by Michael Wonder on 19 Jun 2018
Statement from deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
19 June 2018 - Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. ...
Posted by Michael Wonder on 19 Jun 2018
Bipartisan group of senators asks FDA to examine drug shortages
18 June 2018 - A bipartisan group of senators is asking the head of the FDA to provide recommendations to ...
Posted by Michael Wonder on 18 Jun 2018
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer
18 June 2018 - ImmunoGen today announced that the U.S. FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 18 Jun 2018
FDA issues complete response letter for Duobrii (halobetasol propionate and tazarotene) lotion
18 June 2018 - Ortho Dermatologics, a division of Valeant Pharmaceuticals, today announced that it has received a complete response ...
Posted by Michael Wonder on 18 Jun 2018
Celltrion completes resubmission to FDA for proposed trastuzumab biosimilar
18 June 2018 - Celltrion made a resubmission for the U.S. FDA approval of CT-P6, a proposed biosimilar to Herceptin ...
Posted by Michael Wonder on 17 Jun 2018
Nightstar Therapeutics receives regenerative medicine advanced therapy designation for NSR-REP1 in choroideremia
14 June 2018 - First gene therapy RMAT designation for an inherited retinal disease. ...
Posted by Michael Wonder on 16 Jun 2018
Motif Bio submits NDA for iclaprim
14 June 2018 - Motif Bio today announced the completion of its rolling submission of a new drug application to ...
Posted by Michael Wonder on 14 Jun 2018
FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
14 June 2018 - The U.S. FDA today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied ...
Posted by Michael Wonder on 14 Jun 2018
scPharmaceuticals receives complete response letter from the FDA for Furoscix
13 June 2018 - scPharmaceuticals today announced the Company received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 14 Jun 2018
Mylan provides statement on generic Advair Diskus
13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning ...
Posted by Michael Wonder on 14 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for treatment of refractory or relapsed primary mediastinal large B-cell lymphoma
13 June 2018 - Keytruda is the first anti-PD-1 therapy approved for adult and paediatric patients with refractory PMBCL or who ...
Posted by Michael Wonder on 14 Jun 2018
U.S. FDA approves moxidectin for the treatment of river blindness
13 June 2018 - Medicines Development for Global Health and the World Health Organisation Special Programme for Research and Training in ...
Posted by Michael Wonder on 13 Jun 2018
Sunovion announces FDA acceptance of new drug application for apomorphine sublingual film
12 June 2018 - Sunovion seeks approval for apomorphine sublingual film for the on-demand treatment of OFF episodes associated with Parkinson’s ...