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RSS FeedPosted by Michael Wonder on 16 Feb 2022
Poxel announces FDA fast track status for PXL065 in X linked adrenoleukodystrophy
16 February 2022 - The initiation of the Phase IIa proof of concept clinical study for PXL065 in adrenoleukodystrophy is now ...
Posted by Michael Wonder on 16 Feb 2022
3D printing medical devices: stakeholders weigh in on FDA’s discussion paper
15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point ...
Posted by Michael Wonder on 16 Feb 2022
U.S. FDA accepts Mirati Therapeutics' new drug application for adagrasib as treatment of previously treated KRAS G12C mutated non-small cell lung cancer
15 February 2022 - Mirati Therapeutics today announced that the U.S. FDA accepted the new drug application for adagrasib for ...
Posted by Michael Wonder on 16 Feb 2022
Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by U.S. Food and Drug Administration
15 February 2022 - Foundation Medicine today announced that the U.S. FDA has granted a breakthrough device designation for its circulating ...
Posted by Michael Wonder on 16 Feb 2022
Cardiosense receives FDA breakthrough device designation for algorithm to identify patients at risk of decompensated heart failure
15 February 2022 - Cardiosense announced today that the U.S. FDA has granted the company breakthrough device status for its ...
Posted by Michael Wonder on 16 Feb 2022
Rapid Medical receives FDA breakthrough device designation for vasospasm treatment
15 February 2022 - Comaneci temporarily expands blood vessels, recognised as novel device for life-threatening disease. ...
Posted by Michael Wonder on 15 Feb 2022
Theradaptive wins additional FDA breakthrough designation for spinal fusion
15 February 2022 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation for its OsteoAdapt SP Spinal ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 15 Feb 2022
Biogen Alzheimer drug row augers flux in fast FDA approvals
14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation ...
Posted by Michael Wonder on 15 Feb 2022
Senate confirms Califf as FDA chief in tight vote
15 February 2022 - The narrow 50-46 decision underscored the divisions on both sides of the aisle over agency policies on ...
Posted by Michael Wonder on 15 Feb 2022
With no votes to spare, Senate advances Califf’s FDA nomination toward final vote
14 February 2022 - In a dramatically close procedural vote Monday night, the Senate voted 49-45 to advance Robert Califf’s ...
Posted by Michael Wonder on 14 Feb 2022
Medscape awarded contract from FDA to develop educational programming focused on biosimilars
14 February 2022 - Medscape Education has been awarded a contract from the U.S. FDA for the development of an ...
Posted by Michael Wonder on 14 Feb 2022
Confirmation fight over Biden's FDA nominee comes to a head
14 February 2022 - An intense confirmation battle over Robert Califf, President Biden’s nominee to lead the FDA, is poised ...
Posted by Michael Wonder on 14 Feb 2022
Avion Pharmaceuticals, an Alora Pharmaceuticals company, announces the FDA approval and availability of Dhivy for the treatment of Parkinson's disease
14 February 2022 - Parkinson's disease treatment is the first and only carbidopa/levodopa tablet designed to be divided for precise dosing. ...
Posted by Michael Wonder on 14 Feb 2022
Bavarian Nordic announces breakthrough therapy designation for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
14 February 2022 - Bavarian Nordic announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's vaccine ...