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RSS FeedPosted by Michael Wonder on 21 Jun 2018
Acurx's lead antibiotic product candidate, ACX-362E for Clostridium difficile infection
20 June 2018 - Acurx Pharmaceuticals today announced that the U.S. FDA has designated the Company's lead antibiotic product candidate, ACX-362E, ...
Posted by Michael Wonder on 21 Jun 2018
The ‘right to try’ could cost dying patients a fortune
21 June 2018 - Small biotech considers giving access under new U.S. law. ...
Posted by Michael Wonder on 20 Jun 2018
Finding cancer patients is the pharma industry’s unlikely challenge
20 June 2018 - Doctors will need to test 100 patients to find one candidate. ...
Posted by Michael Wonder on 20 Jun 2018
Budget matters: infrastructure to support robust generic drug competition
18 June 2018 - The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of ...
Posted by Michael Wonder on 20 Jun 2018
Novartis receives FDA approval for inclusion of new evidence that Cosentyx inhibits progression of joint structural damage in psoriatic arthritis
19 June 2018 - New prescribing information to include data demonstrating Cosentyx (secukinumab) slows progression of joint structural damage associated with ...
Posted 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
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 ...