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RSS FeedPosted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), ...
Posted by Michael Wonder on 24 Jun 2021
FDA accepts application for Genentech’s port delivery system with ranibizumab for treatment of wet age related macular degeneration
24 June 2021 - If approved, PDS would be the first and only eye implant with continuous drug delivery that offers ...
Posted by Michael Wonder on 23 Jun 2021
FDA chief under fire over Alzheimer’s drug decision
22 June 2021 - US regulator’s approval of controversial treatment shows it is too close to Big Pharma, say critics. ...
Posted by Michael Wonder on 23 Jun 2021
FDA should lead the way on new ALS treatments, not Canada and Europe
22 June 2021 - Following the FDA’s recent decision to give the green light to aducanumab, the first treatment approved ...
Posted by Michael Wonder on 23 Jun 2021
Aducanumab (Aduhelm) information
22 June 2021 - The FDA has posted the CDER’s Office of Neurology’s Summary Review Memorandum describing the agency’s extensive ...
Posted by Michael Wonder on 22 Jun 2021
FDA approved Biogen Alzheimer’s drug despite some staff concerns
22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works. ...
Posted by Michael Wonder on 22 Jun 2021
New drug could cost the Government as much as it spends on NASA
22 June 2021 - The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” ...
Posted by Michael Wonder on 22 Jun 2021
Targovax receives fast track designation for ONCOS-102 in melanoma
22 June 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in PD-1-refractory ...
Posted by Michael Wonder on 22 Jun 2021
Acrux receives approval from the FDA for its generic version of Jublia
22 June 2021 - Acrux is pleased to announce that the US FDA has granted approval of the Company’s generic version ...
Posted by Michael Wonder on 22 Jun 2021
Medtronic receives FDA expanded approval for Arctic Front family of cardiac cryoablation catheters for initial use for recurrent symptomatic paroxysmal atrial fibrillation
21 June 2021 - First and only approval to indicate cryoablation as an initial rhythm control strategy. ...
Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021. ...
Posted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
Posted by Michael Wonder on 21 Jun 2021
Agios submits new drug application to FDA for mitapivat for treatment of adults with pyruvate kinase deficiency
21 June 2021 - Agios Pharmaceuticals today announced that it has submitted a new drug application for mitapivat to the U.S. ...