Lin BioScience receives US FDA fast track designation for LBS-007

27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...

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Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors

26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...

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Satsuma Pharmaceuticals and SNBL receive FDA acceptance of NDA resubmission of STS101 for the acute treatment of migraine with or without aura

26 November 2024 - Satsuma Pharmaceuticals and its corporate parent Shin Nippon Biomedical Laboratories are pleased to announce that the ...

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Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review

26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter. ...

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Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA

26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...

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Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome

26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...

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Alnylam announces US FDA acceptance of supplemental new drug application for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy

25 November 2024 - PDUFA date set for 23 March 2025. ...

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Intellia Therapeutics announces FDA regenerative medicine advanced therapy designation granted to nexiguran ziclumeran for the treatment of hereditary transthyretin amyloidosis with polyneuropathy

25 November 2024 - Intellia Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to nexiguran ...

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Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment

18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...

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The trade-off between accelerated cancer drug approvals and patient preferences

18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...

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Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers

25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...

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US FDA approves AOP Health’s Rapiblyk (landiolol) for atrial fibrillation and atrial flutter in the critical care setting

27 November 2024 - AOP Orphan Pharmaceuticals announced that the US FDA has granted regulatory approval for Rapiblyk (landiolol) in the ...

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Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma

25 November 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, ...

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‘We dodged a bullet’: biotech and pharma react to selection of Marty Makary for FDA commissioner

23 November 2024 - Many appear cautiously optimistic about Trump’s intended pick. ...

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Amneal resubmits DHE auto-injector new drug application and receives US FDA approval of exenatide, its first generic injectable GLP-1 agonist

21 November 2024 - Potential first and only DHE auto-injector for tough-to-treat migraines and cluster headaches. ...

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