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RSS FeedPosted by Michael Wonder on 11 Apr 2022
Poxel announces PXL770 awarded FDA fast track designation for X-linked adrenoleukodystrophy
11 April 2022 - Poxel is pleased to announce that the U.S. FDA has granted fast track designation to PXL770 ...
Posted by Michael Wonder on 11 Apr 2022
Spectrum Pharmaceuticals announces FDA acceptance of BLA resubmission for eflapegrastim
11 April 2022 - FDA has assigned 9 September 2022 as the PDUFA date. ...
Posted by Michael Wonder on 11 Apr 2022
Hugel says FDA’s complete response letter will not affect Letybo approval
11 April 2022 - Hugel said a complete response letter from the U.S. FDA on botulinum toxin Letybo requires supplementary ...
Posted by Michael Wonder on 11 Apr 2022
Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision
8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...
Posted by Michael Wonder on 10 Apr 2022
Amphastar receives FDA approval for ganirelix acetate injection
8 April 2022 - Amphastar Pharmaceuticals announced that the U.S. FDA has approved the Company's abbreviated new drug application for ganirelix ...
Posted by Michael Wonder on 10 Apr 2022
‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval
9 April 2022 - Whither accelerated approval? ...
Posted by Michael Wonder on 09 Apr 2022
Joint statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf on ensuring access to safe and effective treatments
8 April 2022 - Ensuring the availability of innovative interventions for people is a shared priority for both the CMS and ...
Posted by Michael Wonder on 07 Apr 2022
Clayton Pharmaceuticals and VistaPharm receive FDA approval for sucralfate oral suspension
7 April 2022 - Approval validates the use of novel pathway for bioequivalence of complex generic drug products, which increases ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 06 Apr 2022
BioXcel Therapeutics announces FDA approval of Igalmi (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
6 April 2022 - U.S. commercial launch planned for Q2 2022. ...
Posted by Michael Wonder on 06 Apr 2022
Dialectic Therapeutics announces DT2216 has received fast track designation from the FDA for adult patients with relapsed or refractory peripheral and cutaneous T-cell lymphoma
5 April 2022 - Dialectic Therapeutics today announced that the U.S. FDA has granted fast track designation to DT2216 for adult ...
Posted by Michael Wonder on 06 Apr 2022
FDA approves Novartis Vijoice (alpelisib) as first and only treatment for select patients with PIK3CA related overgrowth spectrum
6 April 2022 - Approval based on real world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction ...
Posted by Michael Wonder on 05 Apr 2022
Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.
5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...