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RSS FeedPosted by Michael Wonder on 12 Dec 2017
Regeneron announces FDA acceptance of sBLA filing for 12 week dosing of Eylea (aflibercept) injection for patients with wet AMD
11 December 2017 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the Company's supplemental biologics ...
Posted by Michael Wonder on 12 Dec 2017
SIGA Technologies announces FDA submission of its new drug application for oral TPOXX (tecovirimat) to treat smallpox
11 December 2017 - Company requests priority review of TPOXX new drug application. ...
Posted by Michael Wonder on 12 Dec 2017
FDA accepts supplemental biologics license application, assigns priority review to Merck’s Keytruda (pembrolizumab) for treatment of relapsed or refractory primary mediastinal large B-cell lymphoma
11 December 2017 - Data for Keytruda in patients with relapsed or refractory PMBCL show overall response rate of 41% ...
Posted by Michael Wonder on 11 Dec 2017
BioVie receives FDA fast track designation for BIV201 for the treatment of refractory ascites due to advanced liver cirrhosis
11 December 2017 - BioVie announced today that the US FDA has granted fast track designation for BIV201 (continuous infusion terlipressin), ...
Posted by Michael Wonder on 11 Dec 2017
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
11 December 2017 - The U.S. FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control ...
Posted by Michael Wonder on 11 Dec 2017
Galcanezumab is the first of three investigational, non-opioid treatments in Lilly's pain portfolio
11 December 2017 - Eli Lilly announced today that the U.S.FDA has accepted a biologics license application to review galcanezumab ...
Posted by Michael Wonder on 11 Dec 2017
Drug makers continue to owe FDA numerous clinical trials
7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...
Posted by Michael Wonder on 11 Dec 2017
Rhizen Pharmaceuticals S.A. receives FDA fast track designation for RP6530 (tenalisib), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma
9 December 2017 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for RP6530 (tenalisib), the ...
Posted by Michael Wonder on 09 Dec 2017
Engaging with patients on health policy changes: an urgent issue
8 December 2017 - Back in the 1980s, when I was practicing as a faculty primary care physician at an academic ...
Posted by Michael Wonder on 08 Dec 2017
Aptinyx granted fast track designation, initiates Phase 1 for second clinical candidate, NYX-783, in post-traumatic stress disorder
7 December 2017 - Data presented at American College of Neuropsychopharmacology Annual Meeting demonstrate robust and durable response in models relevant ...
Posted by Michael Wonder on 08 Dec 2017
Remarks from FDA Commissioner as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
7 December 2017 - FDA Commissioner Gottlieb provides testimony before the U.S. Senate HELP Committee on the agency’s implementation of the ...
Posted by Michael Wonder on 08 Dec 2017
Statement from FDA Commissioner on advancing new digital health policies to encourage innovation, bring efficiency and modernisation to regulation
7 December 2017 - Today we’re announcing three new, significant policy documents to advance the FDA’s approach to the development ...
Posted by Michael Wonder on 08 Dec 2017
Concentric Analgesics receives FDA fast track designation for CA-008 for post-surgical pain
7 December 2017 - Novel pro-drug with unique mechanism of action takes on the opioid crisis. ...
Posted by Michael Wonder on 08 Dec 2017
Acorda resubmits new drug application for Inbrija (CVT-301, levodopa inhalation powder)
7 December 2017 - Acorda Therapeutics announced the resubmission of its new drug application for Inbrija to the U.S. FDA. ...
Posted by Michael Wonder on 07 Dec 2017
FDA required studies of approved drugs make a big difference for public health
7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...