Blog
RSS FeedPosted by Michael Wonder on 17 Aug 2021
Agios announces FDA acceptance and priority review of new drug application for mitapivat for treatment of adults with pyruvate kinase deficiency
17 August 2021 - PDUFA date set for 17 February 2022. ...
Posted by Michael Wonder on 16 Aug 2021
Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
16 August 2021 - Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine ...
Posted by Michael Wonder on 14 Aug 2021
Ipsen announces withdrawal of palovarotene NDA, confirming intention to resubmit following additional data analyses
13 August 2021 - This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May ...
Posted by Michael Wonder on 10 Aug 2021
Dermavant announces FDA acceptance for filing of new drug application for tapinarof cream for the treatment of adults with plaque psoriasis
10 August 2021 - FDA PDUFA action expected in Q2 2022. ...
Posted by Michael Wonder on 10 Aug 2021
FDA accepts application for Merck’s Keytruda (pembrolizumab) as single agent for certain patients with MSI-H/dMMR advanced endometrial carcinoma
10 August 2021 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 10 Aug 2021
Acer Therapeutics and Relief Therapeutics announce submission of a new drug application to the U.S. FDA for ACER-001 for treatment of urea cycle disorders
9 August 2021 - Acer Therapeutics and Relief Therapeutics today announced the submission of a new drug application to the U.S. ...
Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 06 Aug 2021
Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA
5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...
Posted by Michael Wonder on 05 Aug 2021
Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer
5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...
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
Marinus Pharmaceuticals submits new drug application to FDA for ganaxolone for the treatment of seizures associated with CDKL5 deficiency disorder
3 August 2021 - Marinus Pharmaceuticals today announced the submission of a new drug application to the FDA for the ...
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 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 ...