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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Jun 2021
United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review
16 June 2021 - FDA action expected in October 2021. ...
Posted by Michael Wonder on 03 Jun 2021
FDA grants priority review for new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
3 June 2021 - PDUFA date of 30 November 2021 set for Oleogel-S10. ...
Posted by Michael Wonder on 01 Jun 2021
CTI BioPharma announces acceptance of NDA granted with priority review of pacritinib for treatment of patients with myelofibrosis
1 June 2021 - PDUFA action date 30 November 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...
Posted by Michael Wonder on 01 Jun 2021
BeyondSpring announces U.S. FDA acceptance and priority review of new drug application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
1 June 2021 - The FDA has set a Prescription Drug User Fee Act target action date for 30 November 2021. ...
Posted by Michael Wonder on 29 May 2021
Ipsen confirms U.S. FDA accepts new drug application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva
28 May 2021 - New drug application granted priority review status, with a decision anticipated on 30 November 2021. ...
Posted by Michael Wonder on 27 May 2021
U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma
26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...