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RSS FeedPosted by Michael Wonder on 13 Dec 2024
Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 13 Dec 2024
Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC
4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...
Posted by Michael Wonder on 13 Dec 2024
Allay Therapeutics receives FDA breakthrough therapy designation for ATX101 for the treatment of post-surgical pain following total knee replacement surgery
4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 12 Dec 2024
Immuneering granted FDA fast track designation for IMM-1-104 in advanced melanoma
12 December 2024 - MM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative ...
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
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 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
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 ...