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RSS FeedPosted by Michael Wonder on 14 Jul 2022
Marinus Pharmaceuticals sells rare paediatric disease priority review voucher for $110 million
14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...
Posted by Michael Wonder on 07 Jul 2022
US FDA awards rare paediatric disease designation to paxalisib for AT/RT, a rare form of childhood brain cancer
6 July 2022 - Kazia Therapeutics is pleased to announce that the U.S. FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 06 Jul 2022
FDA grants priority review to Genentech’s mosunetuzumab for people with relapsed or refractory follicular lymphoma
6 July 2022 - Application is based on results from the pivotal Phase I/II study showing mosunetuzumab induced high and durable ...
Posted by Michael Wonder on 06 Jul 2022
The U.S. FDA accepts and grants priority review for Eisai's biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 26 Jun 2022
Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...
Posted by Michael Wonder on 08 Jun 2022
Allogene Therapeutics announces the FDA granted regenerative medicine advanced therapy designation to ALLO-501A for large B-cell Lymphoma
8 June 2022 - In the ALPHA trials with ALLO-501 and ALLO-501A, treatment was initiated approximately 2 days from enrollment, eliminating ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 06 Jun 2022
GBT’s inclacumab and GBT601 receive U.S. FDA orphan drug and rare paediatric disease designations for the treatment of sickle cell disease
6 June 2022 - Inclacumab is a novel P selectin inhibitor currently in Phase 3 clinical trials to reduce vaso-occlusive ...
Posted by Michael Wonder on 31 May 2022
Y-mAbs Announces FDA acceptance of biologics license application for Omblastys (omburtamab) for the treatment of neuroblastoma for priority review
31 May 2022 - Y-mAbs Therapeutics today announced that the biologics license application for Omblasyts (omburtamab) for the treatment of paediatric ...
Posted by Michael Wonder on 26 May 2022
Reata Pharmaceuticals announces FDA filing acceptance and priority review designation for the NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
26 May 2022 - Application assigned a PDUFA date of 30 November 2022. ...
Posted by Michael Wonder on 25 May 2022
Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates
24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...
Posted by Michael Wonder on 24 May 2022
ImmunoGen announces acceptance of biologics license application for mirvetuximab soravtansine in ovarian cancer by US Food and Drug Administration with priority review
23 May 2022 - PDUFA date is 28 November 2022. ...