Applied Therapeutics announces FDA acceptance and priority review of new drug application for govorestat for the treatment of classic galactosaemia

28 February 2024 - PDUFA target action date of 28 August 2024. ...

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Incyte announces US FDA grants priority review for axatilimab for the treatment of chronic graft versus host disease

27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...

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Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA

27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...

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BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA

27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...

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Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia

27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...

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GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk

26 February 2024 - Submission supported by positive results of a Phase 3 study showing immune response and tolerability in adults ...

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US FDA accepts for priority review the supplemental biologics license application for epcoritamab (Epkinly) for difficult to treat relapsed or refractory follicular lymphoma

26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...

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Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of COPD with type 2 inflammation

23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...

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Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic

22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...

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US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy

21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...

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Linvoseltamab BLA for treatment of relapsed/refractory multiple myeloma accepted for FDA priority review

21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...

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FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma

20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...

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argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy

20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...

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FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma

20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...

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US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review

20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...

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