Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA

15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...

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Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss

9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...

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Albireo sells priority review voucher for $105 million

7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...

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UK MHRA grants GenSight Biologics’ Lumevoq ophthalmic gene therapy Promising Innovative Medicine Designation

6 September 2021 - GenSight Biologics today announced that its gene therapy Lumevoq has been granted Promising Innovative Medicine designation by ...

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European Medicines Agency grants Marinus Pharmaceuticals accelerated assessment of ganaxolone for treatment of CDKL5 deficiency disorder

26 August 2021 - Marinus Pharmaceuticals today announced that the CHMP of the EMA has granted its request for accelerated ...

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FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukaemia

25 August 2021 - Novartis today announced that the US FDA accepted and granted priority review to the company’s new drug ...

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U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease

23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to ...

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Liminal BioSciences announces sale of priority review voucher for USD105 million

9 August 2021 - Liminal BioSciences announced today that its subsidiary ProMetic Biotherapeutics has entered into a definitive agreement to ...

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Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis

9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...

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US tropical disease priority review vouchers: lessons in promoting drug development and access

6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...

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Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer

5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...

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US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

3 August 2021 - Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme. ...

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Mustang Bio receives European Medicines Agency PRIME designation for MB-107 to treat X-linked severe combined immunodeficiency in newly diagnosed infants

2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...

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Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa

26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...

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UK’s MHRA accepts Humanigen’s submission of lenzilumab for marketing authorisation in COVID-19 for expedited rolling review

9 July 2021 - Humanigen today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has ...

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