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RSS FeedPosted by Michael Wonder on 27 Feb 2022
Update on Tyvaso DPI new drug application
24 February 2022 - MannKind Corporation was informed that the U.S. FDA issued an information request to United Therapeutics Corporation ...
Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022. ...
Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022. ...
Posted by Michael Wonder on 22 Feb 2022
The truth about patient access and FDA fast tracking
21 February 2022 - University of Illinois Chicago researchers studied 135 products that received U.S. FDA approval through orphan drug and ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted 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 ...