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RSS FeedPosted by Michael Wonder on 17 Nov 2020
UCB’s Vimpat (lacosamide) now approved by FDA in U.S. for primary generalised tonic-clonic seizures and expanded paediatric use for people living with epilepsy
17 November 2020 - All three Vimpat formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset ...
Posted by Michael Wonder on 17 Nov 2020
Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel
16 November 2020 - Bristol-Myers Squibb today announced that the U.S. FDA has informed the company that its review of ...
Posted by Michael Wonder on 17 Nov 2020
PLx Pharma submits supplemental new drug applications for Vazalore 325 mg and 81 mg to U.S. FDA
16 November 2020 - FDA sets estimated completion review date for the end of February 2021. ...
Posted by Michael Wonder on 17 Nov 2020
Kiniksa announces breakthrough therapy designation granted to vixarelimab for the treatment of pruritus associated with prurigo nodularis
16 November 2020 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation to vixarelimab for the ...
Posted by Michael Wonder on 16 Nov 2020
HHS Secretary Azar says the FDA will move ‘as quickly as possible’ to clear Moderna and Pfizer’s COVID-19 vaccines
16 November 2020 - There should be enough vaccine doses made by Pfizer and Moderna to inoculate roughly 20 million before ...
Posted by Michael Wonder on 16 Nov 2020
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of PNH
16 November 2020 - FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss ...
Posted by Michael Wonder on 16 Nov 2020
Lupin announces FDA filing acceptance of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
16 November 2020 - Lupin Pharmaceuticals announced today that the U.S. FDA has accepted their supplemental new drug application for ...
Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 ...
Posted by Michael Wonder on 15 Nov 2020
Agilent receives expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple negative breast cancer
13 November 2020 - Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the ...
Posted by Michael Wonder on 14 Nov 2020
FDA issues complete response letter for sutimlimab, an investigational treatment for haemolysis in adults with cold agglutinin disease
14 November 2020 - Complete response letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility. ...
Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...
Posted by Michael Wonder on 13 Nov 2020
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer
13 November 2020 - Today, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the ...
Posted by Michael Wonder on 12 Nov 2020
FDA grants a breakthrough device designation for Spiderwort spinal cord technology
12 November 2020 - Spiderwort is pleased to announce that the U.S. FDA has designated CelluBridge, Spiderwort’s spinal cord scaffold implant, ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 12 Nov 2020
BioXcel Therapeutics announces completion of pre-NDA meeting with FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders
11 November 2020 - Initiated rolling submission of new drug application with U.S. FDA. ...