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RSS FeedPosted by Michael Wonder on 01 Apr 2024
Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
Posted by Michael Wonder on 01 Apr 2024
US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
1 April 2024 - Target action date set for 19 November 2024. ...
Posted by Michael Wonder on 29 Mar 2024
LISCure Biosciences receives US FDA fast track designation for LB-P8 for the treatment of primary sclerosing cholangitis
29 March 2024 - Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be ...
Posted by Michael Wonder on 29 Mar 2024
Korean drug for metabolism-related steatohepatitis gets FDA’s fast track designation
28 March 2024 - D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by ...
Posted by Michael Wonder on 28 Mar 2024
IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C
26 March 2024 - PDUFA date set for 24 September 2024. ...
Posted by Michael Wonder on 28 Mar 2024
Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis
27 March 2024 - Once daily oral HIF-PH inhibitor activates physiologic response to manage anaemia. ...
Posted by Michael Wonder on 27 Mar 2024
Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia
26 March 2024 - PDUFA action date set for 26 September 2024. ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 26 Mar 2024
FDA approves Merck’s Winrevair (sotatercept-csrk), a first in class treatment for adults with pulmonary arterial hypertension (WHO Group 1)
26 March 2024 - Winrevair on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures ...
Posted by Michael Wonder on 26 Mar 2024
Johnson & Johnson's nipocalimab granted US FDA fast track designation to reduce the risk of foetal neonatal allo-immune thrombocytopenia in allo-immunised pregnant adults
26 March 2024 - The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported ...
Posted by Michael Wonder on 26 Mar 2024
Tonix Pharmaceuticals receives rare paediatric disease designation from the FDA for TNX-2900 for the treatment of Prader-Willi syndrome
25 March 2024 - TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and ...
Posted by Michael Wonder on 25 Mar 2024
Regeneron provides update on biologics license application for odronextamab
25 March 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued complete response letters for the biologics license ...
Posted by Michael Wonder on 25 Mar 2024
Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
25 March 2024 - Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how Ultomiris may redefine patient journey for ...
Posted by Michael Wonder on 25 Mar 2024
FDA grants Argenica rare paediatric disease designation for ARG-007 in the treatment of HIE
25 March 2024 - Argenica Therapeutics is pleased to announce the US FDA has granted its neuroprotective drug ARG-007 rare ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...