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RSS FeedPosted by Michael Wonder on 17 Aug 2022
US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis
17 February 2022 - Regulatory submission included data from the pivotal MOMENTUM Phase 3 clinical trial that met all primary ...
Posted by Michael Wonder on 16 Aug 2022
FDA accepts supplemental biologics license application for Genentech's Polivy combination for people with previously untreated diffuse large B-cell lymphoma
15 August 2022 - Application is based on pivotal data from the Phase 3 POLARIX study showing Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 16 Aug 2022
Lynparza in combination with abiraterone granted priority review in the US for patients with metastatic castration-resistant prostate cancer
16 August 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent irrespective of ...
Posted by Michael Wonder on 15 Aug 2022
Brainstorm to seek FDA approval for ALS stem cell treatment, despite agency objections
15 August 2022 - Last year, the FDA issued a rare public statement to inform the ALS community that a ...
Posted by Michael Wonder on 15 Aug 2022
Novavax submits application to the U.S. FDA for emergency use authorisation for Novavax COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older
15 August 2022 - If authorised, Novavax' vaccine would be the first protein-based COVID-19 booster for adults. ...
Posted by Michael Wonder on 11 Aug 2022
Menarini Group’s elacestrant granted priority review by the US FDA for patients with ER+/HER2- advanced or metastatic breast cancer
11 August 2022 - US FDA has assigned a Prescription Drug User Fee Act date of 17 February 2023. ...
Posted by Michael Wonder on 09 Aug 2022
CorMedix announces regulatory and manufacturing updates
8 August 2022 - CorMedix today announced a second complete response letter was received from the FDA stating that the DefenCath ...
Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023. ...
Posted by Michael Wonder on 05 Aug 2022
Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
4 August 2022 - Acadia Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...
Posted by Michael Wonder on 03 Aug 2022
Fresenius Kabi’s biologics license application for biosimilar candidate tocilizumab accepted for review by the FDA
1 August 2022 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s 351(k) biologics ...
Posted by Michael Wonder on 03 Aug 2022
Amylyx Pharmaceuticals announces FDA Advisory Committee will reconvene to review new drug application for AMX0035 for the treatment of ALS
3 August 2022 - Amylyx Pharmaceuticals today announced that the U.S. FDA Peripheral and Central Nervous System Drugs Advisory Committee will ...
Posted by Michael Wonder on 03 Aug 2022
MediWound announces US FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
3 August 2022 - Prescription Drug User Fee Act target date of 1 January 2023. ...
Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023. ...
Posted by Michael Wonder on 31 Jul 2022
Gilead Sciences statement on FDA acceptance of new drug application for investigational lenacapavir
27 July 2022 - Gilead Sciences today announced that the U.S. FDA accepted for review the new drug application resubmission for ...