Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)

1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...

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European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...

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EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...

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COVID-19 vaccine safety report (1 December 2022)

1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...

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FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation

1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...

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Y-mAbs announces complete response letter for omburtamab biologics license application

1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...

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Citius Pharmaceuticals announces US FDA acceptance of biologics license application of denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma

1 December 2022 - PDUFA target action date is 28 September 2023. ...

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FDA grants fast track designation to Nuvectis Pharma's NXP800 for the treatment of platinum-resistant, ARID1A mutated ovarian carcinoma

1 December 2022 - Nuvectis Pharma today announced that the US FDA has granted fast track designation to NXP800 for the ...

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Scynexis announces FDA approval of second indication for Brexafemme (ibrexafungerp) for reduction in incidence of recurrent vulvovaginal candidiasis

1 December 2022 - Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over ...

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Oncolytics Biotech receives FDA fast track designation for the treatment of advanced/metastatic pancreatic cancer

1 December 2022 - FDA fast rack designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective ...

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Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam

30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...

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FDA approves first faecal microbiota product

30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency.  ...

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How CSL priced the world’s most expensive drug

1 December 2022 - When blood products giant CSL announced last week it had been given US regulatory approval for ...

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Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review

30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children ...

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Swiss National Council votes to accept FDA approved medical devices

29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...

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