BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer

23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...

Read more →

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 ...

Read more →

MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran

8 June 2022 - The UK medicines regulator has awarded Alnylam’s RNAi based therapy zilebesiran for hypertension an ‘innovation passport‘, ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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. ...

Read more →

Travere Therapeutics announces FDA acceptance and priority review of new drug application for sparsentan for the treatment of IgA nephropathy

16 May 2022 - PDUFA target action date of 17 November 2022. ...

Read more →

Bridgebio Pharma sells rare pediatric disease priority review voucher for $110 million

13 May 2022 - Entered into a definitive agreement to sell the rare paediatric disease priority review voucher it obtained in ...

Read more →

PolarityTE announces FDA regenerative medicine advanced therapy designation granted to SkinTE

13 May 2022 - PolarityTE today announced that the U.S. FDA granted a regenerative medicine advanced therapy designation to SkinTE under ...

Read more →

Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial

4 May 2022 - First Phase 3 trial in this setting to show improved overall survival with an immunotherapy added ...

Read more →