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RSS FeedPosted by Michael Wonder on 20 Dec 2022
F2G announces FDA filing acceptance of new drug application for Olorofim for the treatment of invasive fungal infections
19 December 2022 - Application submitted under priority review with PDUFA target action date set for 17 June 2023. ...
Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU. ...
Posted by Michael Wonder on 20 Dec 2022
HUTCHMED initiates rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory colorectal cancer
19 December 2022 - Company plans to complete rolling submission to the US in the first half of 2023, followed by ...
Posted by Michael Wonder on 18 Dec 2022
US FDA approves Vraylar (cariprazine) as an adjunctive treatment for major depressive disorder
16 December 2022 - Approval marks fourth indication for Vraylar, backed by proven efficacy and well-established tolerability as an adjunctive treatment ...
Posted by Michael Wonder on 17 Dec 2022
AbbVie submits supplemental new drug application to US FDA to support new indication of Linzess (linaclotide) for functional constipation in children and adolescents 6 to 17 years of age
16 December 2022 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...
Posted by Michael Wonder on 16 Dec 2022
Soligenix announces submission of new drug application to the FDA for HyBryte in the treatment of cutaneous T-cell lymphoma
15 December 2022 - Soligenix announced today that it submitted a new drug application to the US FDA for HyBryte (synthetic ...
Posted by Michael Wonder on 15 Dec 2022
Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer
15 December 2022 - AstraZeneca and MSD today announced that the US FDA has informed AstraZeneca that it will extend ...
Posted by Michael Wonder on 13 Dec 2022
Galera submits new drug application for avasopasem for severe oral mucositis
12 December 2022 - NDA based on two positive randomised, double-blinded, placebo-controlled trials which enrolled a total of 678 patients. ...
Posted by Michael Wonder on 10 Dec 2022
FDA accepts Biogen biologics license application for BIIB800, a biosimilar candidate referencing Actemra (tocilizumab)
9 December 2022 - Biogen announced that the US FDA has accepted for review the abbreviated biologics license application for ...
Posted by Michael Wonder on 10 Dec 2022
Janssen submits biologics license application to US FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
9 December 2022 - Janssen today announced the submission of a biologics license application to the US FDA for talquetamab ...
Posted by Michael Wonder on 08 Dec 2022
Visiox Pharma announces FDA acceptance of new drug application for glaucoma
8 December 2022 - Visiox Pharma today announced that it has received notification from the US FDA that the agency ...
Posted by Michael Wonder on 07 Dec 2022
US FDA accepts for priority review the biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...
Posted by Michael Wonder on 07 Dec 2022
Ocuphire Pharma announces submission of new drug application to FDA for Nyxol eye drops for reversal of mydriasis
6 December 2022 - NDA supported by positive Phase 3 data demonstrating rapid reversal of dilated eyes and favourable safety profile ...
Posted by Michael Wonder on 07 Dec 2022
Sage Therapeutics and Biogen complete rolling submission of new drug application for zuranolone in the treatment of major depressive disorder and post-partum depression
6 December 2022 - Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and ...
Posted by Michael Wonder on 02 Dec 2022
Y-mAbs announces complete response letter for omburtamab biologics license application
1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...