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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Afraid of pharma pushback, a health data broker puts up a barrier to drug pricing information

1 December 2022 - At a time when many Americans are clamouring for more transparency into prescription drug pricing, one ...

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ICER publishes evidence report on fezolinetant for vasomotor symptoms associated with menopause

1 December 2022 - Evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for ...

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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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argenx enters into agreement to acquire priority review voucher

30 November 2022 - argenx today announced an agreement to acquire a US FDA priority review voucher for $102 million. ...

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Aldeyra Therapeutics submits new drug application to the US FDA for reproxalap for the treatment of signs and symptoms of dry eye disease

29 November 2022 - Aldeyra Therapeutics today announced the submission of a new drug application to the US FDA for ...

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Roche withdraws Tecentriq from US bladder cancer indication

29 November 2022 - Roche has voluntarily withdrawn the US indication of Tecentriq for treating a form of bladder cancer ...

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