On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery

3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...

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Retrotope granted rare paediatric disease designation from FDA for lead development candidate, RT001, in two life-threatening neurodegenerative indications

25 February 2021 - RT001 also granted fast track designation by FDA in Friedreich’s ataxia. ...

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Antengene announces new drug application for ATG-010 (selinexor) granted priority review by China's NMPA

23 February 2021 - Antengene today announced that China's National Medical Products Administration has granted priority review to the new drug ...

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U.S. FDA accepts for priority review Pfizer's application for Ticovac (tick-borne encephalitis vaccine)

23 February 2021 - If approved, the vaccine may help reduce the risk of tick-borne encephalitis for people traveling to endemic ...

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FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer

16 February 2021 - FDA target action date is 16 August 2021 ...

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Forge Biologics receives FDA fast track, orphan drug, and rare paediatric disease designations for FBX-101 gene therapy for patients with Krabbe disease

16 February 2021 - FBX-101 is a first-in-human gene therapy utilising an adeno-associated virus to deliver a functioning copy of the ...

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Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum

16 February 2021 - FDA stated it is not currently planning to hold an advisory committee meeting. ...

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Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of Krabbe disease with PLX-300

10 February 2021 - Polaryx Therapeutics announced today that it has received both rare paediatric disease and orphan drug designations for ...

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Rescindo Therapeutics’ RSC-57 receives FDA orphan drug designation and rare paediatric disease designation for Kabuki syndrome

12 February 2021 - Rescindo Therapeutics announced today that the U.S. FDA has granted orphan drug designation and rare paediatric disease ...

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FDA grants Actinogen rare paediatric disease designation in Fragile X syndrome

5 February 2021 - Actinogen is pleased to announce that the United States FDA has granted Actinogen’s drug Xanamem rare paediatric ...

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Aruvant announces the EMA granted PRIME designation to ARU-1801 for the treatment of sickle cell disease

3 February 2021 - Aruvant Sciences today announced that the EMA granted PRIME designation to ARU-1801, a one-time investigational gene therapy ...

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Chinook receives rare paediatric disease designation from U.S. FDA for CHK-336 for treatment of primary hyperoxaluria

2 February 2021 - CHK-336 on track for Phase 1 clinical trial initiation in the second half of 2021. ...

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Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma

1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...

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Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA

1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...

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M6P Therapeutics receives six rare paediatric disease designations from the U.S. FDA for company’s deep pipeline of programs for lysosomal storage disorders

28 January 2021 - U.S. FDA also grants two orphan drug designations for the company’s gene therapy programs for Gaucher disease ...

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