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RSS FeedPosted 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 03 Aug 2021
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
3 August 2021 - Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme. ...
Posted by Michael Wonder on 03 Aug 2021
GSK files for licensure of MMR vaccine in the US
2 August 2021 - GSK seeks US approval of Priorix vaccine licensed in more than 100 countries. ...
Posted by Michael Wonder on 29 Jul 2021
Ardelyx receives complete response letter from U.S. FDA for new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
29 July 2021 - Ardelyx today announced that it has received a complete response letter from the U.S. FDA regarding ...
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 29 Jul 2021
FDA accepts application for Genentech’s faricimab for the treatment of wet age-related macular degeneration and diabetic macular oedema
28 July 2021 - Across four Phase 3 studies, approximately half of patients receiving faricimab could extend treatment time to every ...
Posted by Michael Wonder on 28 Jul 2021
Mycovia Pharmaceuticals announces U.S. FDA acceptance and priority review of new drug application for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
28 July 2021 - Six month priority review granted for oteseconazole with PDUFA target action date set for 27 January 2022. ...
Posted by Michael Wonder on 26 Jul 2021
Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa
26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...
Posted by Michael Wonder on 23 Jul 2021
GBT provides regulatory and pipeline updates in sickle cell disease
22 July 2021 - Submits supplemental new drug application to the U.S. FDA for Oxbryta (voxelotor) in children with SCD ages ...
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 20 Jul 2021
Ardelyx provides regulatory update on new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
19 July 2021 - Ardelyx today announced that it received a letter from the U.S. FDA on 13 July 2021, ...
Posted by Michael Wonder on 19 Jul 2021
Aquestive Therapeutics announces FDA acceptance of new drug application resubmission for Libervant (diazepam) buccal film
19 July 2021 - Prescription Drug User Fee Act target goal date set for 23 December 2021. ...
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 ...