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RSS FeedPosted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022. ...
Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 22 Nov 2021
Bristol Myers Squibb announces new PDUFA date for mavacamten
19 November 2021 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the new ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...
Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...
Posted by Michael Wonder on 04 Aug 2021
FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day
3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...
Posted by Michael Wonder on 03 Aug 2021
The FDA finally gets moving on Pfizer
2 August 2021 - The agency will now ‘sprint’ to grant full vaccine approval. ...
Posted by Michael Wonder on 29 Jul 2021
Congress presses the FDA to move faster on ALS drugs
29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...
Posted by Michael Wonder on 29 Jul 2021
FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid COVID-19 surge
29 July 2021 - The US FDA insists it is working as quickly as possible to review applications for full ...
Posted by Michael Wonder on 28 Jul 2021
FDA says its 'working as quickly as possible' to review for full approval of vaccines
27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...