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RSS FeedPosted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 10 Sep 2021
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 ...
Posted by Michael Wonder on 09 Sep 2021
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. ...
Posted by Michael Wonder on 06 Sep 2021
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 ...
Posted by Michael Wonder on 28 Aug 2021
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 ...
Posted by Michael Wonder on 25 Aug 2021
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 ...
Posted by Michael Wonder on 23 Aug 2021
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 ...
Posted by Michael Wonder on 10 Aug 2021
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 ...
Posted by Michael Wonder on 09 Aug 2021
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 ...
Posted by Michael Wonder on 08 Aug 2021
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 ...
Posted by Michael Wonder on 05 Aug 2021
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 ...
Posted by Michael Wonder on 03 Aug 2021
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. ...
Posted by Michael Wonder on 03 Aug 2021
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 ...
Posted by Michael Wonder on 26 Jul 2021
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 ...
Posted by Michael Wonder on 11 Jul 2021
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 ...