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 ...

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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. ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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ICER releases draft evidence report on treatment for post-traumatic stress disorder

26 March 2024 - Public comment period now open until 22 April 2024; requests to make oral comment during public ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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US FDA approves broad new labels for Esperion’s Nexletol and Nexlizet to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use

22 March 2024 - Esperion today announced that the US FDA has approved broad new label expansions for Nexletol (bempedoic acid) ...

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FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

22 March 2024 - Today, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with FRα positive, platinum-resistant epithelial ...

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