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RSS FeedPosted by Michael Wonder on 18 Feb 2022
Immune-Onc Therapeutics receives FDA fast track designation for IO-202, the first anti-LILRB4 myeloid checkpoint inhibitor, for the treatment of relapsed or refractory acute myeloid leukaemia
17 February 2022 - Immune-Onc Therapeutics today announced that the U.S. FDA has granted fast track designation for IO-202, a first ...
Posted by Michael Wonder on 18 Feb 2022
Agios announces FDA approval of Pyrukynd (mitapivat) as first disease-modifying therapy for haemolytic anaemia in adults with pyruvate kinase deficiency
17 February 2022 - Company to provide robust patient access programs, including $0 copays and free medication for eligible patients. ...
Posted by Michael Wonder on 18 Feb 2022
Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma
18 February 2022 - Fast track designation proves Dizal's world leading capability of developing potential first-in-class and much needed therapy to ...
Posted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
Posted by Michael Wonder on 17 Feb 2022
Agios wins FDA approval for pill to treat rare blood disease
17 February 2022 - The Cambridge company’s CEO says it has the potential to become a blockbuster drug. ...
Posted by Michael Wonder on 17 Feb 2022
Lupin announces FDA approval of supplemental new drug application for Solosec (secnidazole) in adolescents for both the treatment of bacterial vaginosis in females and trichomoniasis
17 February 2022 - Lupin Pharmaceuticals today announced that the U.S. FDA has approved the company's supplemental new drug application to ...
Posted by Michael Wonder on 16 Feb 2022
Acadia Pharmaceuticals announces resubmission of supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) to treat Alzheimer’s disease psychosis
16 February 2022 - Acadia Pharmaceuticals announced today that it has resubmitted its supplemental new drug application for pimavanserin for ...
Posted 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
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 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. ...