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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 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 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 08 Jul 2021
Tezepelumab regulatory submission accepted and granted FDA priority review in the US for the treatment of patients with asthma
8 July 2021 - Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a ...
Posted by Michael Wonder on 06 Jul 2021
FDA grants priority review for Levo Therapeutics’ new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
6 July 2021 - Levo Therapeutics announced today that the U.S. FDA has granted priority review for its new drug application ...
Posted by Michael Wonder on 01 Jul 2021
LEXEO Therapeutics receives rare paediatric disease designation and orphan drug designation for LX2006 for the treatment of Friedreich’s ataxia
30 June 2021 - Phase I/II clinical trial in patients with cardiomyopathy associated with Friedreich’s ataxia expected to initiate in 2021. ...
Posted by Michael Wonder on 17 Jun 2021
Agenus announces U.S. FDA acceptance and priority review of balstilimab biologics license application for the treatment of recurrent or metastatic cervical cancer
17 June 2021 - Agenus today announced that the U.S. FDA has accepted Agenus’ biologics license application for balstilimab, an ...