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RSS FeedPosted by Michael Wonder on 26 Jun 2021
Mirati Therapeutics' adagrasib receives breakthrough therapy designation from U.S. FDA for patients with advanced non-small cell lung cancer harbouring the KRASG12C mutation
24 June 2021 - Mirati Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to adagrasib for ...
Posted by Michael Wonder on 25 Jun 2021
Aquestive Therapeutics resubmits new drug application for Libervant (diazepam) buccal film
24 June 2021 - Anticipates FDA PDUFA goal date in late 2021. ...
Posted by Michael Wonder on 25 Jun 2021
Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children
23 June 2021 - Application seeks two paediatric indications, including an age-appropriate new weight-based oral suspension formulation. ...
Posted by Michael Wonder on 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 24 Jun 2021
Alnylam announces U.S. FDA acceptance of new drug application for investigational vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis
24 June 2021 - PDUFA date set for 14 April 2022. ...
Posted by Michael Wonder on 24 Jun 2021
Biogen expects slow Alzheimer’s drug uptake, may reset price
24 June 2021 - Company faces uproar over $56,000 a year price tag for Aduhelm. ...
Posted by Michael Wonder on 24 Jun 2021
Santen receives FDA approval for Verkazia (cyclosporin 0.1% ophthalmic emulsion) for the treatment of vernal keratoconjunctivitis in children and adults
24 June 2021 - Santen today announced that the U.S. FDA has approved Verkazia (cyclosporin 0.1% ophthalmic emulsion eye drops) for ...
Posted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...
Posted 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” ...