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RSS FeedPosted by Michael Wonder on 20 Jun 2018
Caladrius receives FDA regenerative medicine advanced therapy designation for CD34+ cell therapy for treating refractory angina
19 June 2018 - Caladrius Biosciences announces today that the U.S. FDA has granted regenerative medicine advanced therapy designation to the ...
Posted 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
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 19 Jun 2018
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
19 June 2018 - Publication of updated Q&As and practical guidance. ...
Posted by Michael Wonder on 19 Jun 2018
Sandoz Canada becomes the first Canadian pharmaceutical company to enter the medical cannabis field
19 June 2018 - Sandoz Canada and Tilray finalise alliance to provide Canadians with greater access to high-quality, non-combustible medical cannabis ...
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 19 Jun 2018
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products
19 June 2018 - The EMA published in July 2017 a guideline for first‐in‐human drug studies. ...
Posted by Michael Wonder on 19 Jun 2018
Octapharma announces approval of new Nuwiq product strengths in Europe, increasing dosing flexibility for patients with haemophilia A
18 June 2018 - Octapharma announced today that the EMA has approved an extension of marketing authorisation for its human cell ...
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 ...