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RSS FeedPosted 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. ...
Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 28 Jun 2021
Eagle Pharmaceuticals announces FDA maintains prioritisation of ANDA for vasopressin
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end. ...
Posted by Michael Wonder on 27 Jun 2021
Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US
26 June 2021 - New PDUFA action date for Brixadi set for 15 December 2021. ...
Posted by Michael Wonder on 26 Jun 2021
AbbVie provides update regarding Rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the U.S.
25 June 2021 - AbbVie today announced that the U.S. FDA has informed the company that the FDA will not ...
Posted by Michael Wonder on 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...
Posted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...
Posted by Michael Wonder on 11 Jun 2021
Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis
11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...