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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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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Lisata Therapeutics announces US FDA rare paediatric disease designation granted to LSTA1 for the treatment of osteosarcoma

21 March 2024 - Lisata Therapeutics today announced that the US FDA has granted rare paediatric disease designation to LSTA1, the ...

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FDA approves non-steroidal treatment for Duchenne muscular dystrophy

21 March 2024 - Today, the US FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne muscular dystrophy in ...

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Phanes Therapeutics' PT886 granted fast track designation for the treatment of patients with metastatic claudin 18.2 positive pancreatic adenocarcinoma by the FDA

20 March 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT886 for the ...

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Spevigo approved for expanded indications in China and the US

19 March 2024 - The US FDA’s approval expands the use of Spevigo to include the treatment of generalised pustular psoriasis in ...

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