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RSS FeedPosted by Michael Wonder on 11 Apr 2022
Eton Pharmaceuticals announces FDA approval of cysteine hydrochloride injection
11 April 2022 - Eton Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its cysteine ...
Posted 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 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
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
ATAGI statement on use of booster doses in adolescents aged 12-15 years
8 April 2022 - A statement from the ATAGI on booster doses in adolescents aged 12-15 years. ...
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 08 Apr 2022
TGA approved Yuflyma
8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...
Posted by Michael Wonder on 08 Apr 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine (Comirnaty), for use as a booster for individual aged 12–15 years old
8 April 2022 - The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, Comirnaty, for use as a ...
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 07 Apr 2022
TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage
7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...
Posted by Michael Wonder on 07 Apr 2022
COVID-19 vaccine weekly safety report (7 April 2022)
7 April 2022 - To 3 April 2022, the TGA has received 511 reports which have been assessed as likely to ...