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RSS FeedPosted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...
Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for ...
Posted by Michael Wonder on 12 Dec 2024
Intra-Cellular Therapies submits supplemental new drug application to FDA for Caplyta (lumateperone) for the treatment of major depressive disorder as adjunctive therapy
3 December 2024 - The sNDA submission is based on positive results from Studies 501 and 502 demonstrating Caplyta’s robust anti-depressant ...
Posted by Michael Wonder on 11 Dec 2024
Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada
9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...
Posted by Michael Wonder on 11 Dec 2024
Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
Posted by Michael Wonder on 11 Dec 2024
FDA approves Acetadote sNDA
9 December 2024 - New dosing regimen simplifies administration. ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
EMA publishes agenda for 9-12 December 2024 CHMP meeting
9 December 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2024
MeiraGTx granted FDA regenerative medicine advanced therapy designation for AAV2-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia
9 December 2024 - MeiraGTx today announced that the US FDA has granted regenerative medicine advanced therapy designation to AAV2-hAQP1 for ...
Posted by Michael Wonder on 10 Dec 2024
FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...
Posted by Michael Wonder on 10 Dec 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 10 Dec 2024
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 07 Dec 2024
FDA accepts supplemental biologics license application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a ...