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RSS FeedPosted by Michael Wonder on 03 Mar 2021
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 ...
Posted by Michael Wonder on 26 Feb 2021
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. ...
Posted by Michael Wonder on 24 Feb 2021
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 ...
Posted by Michael Wonder on 24 Feb 2021
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 ...
Posted by Michael Wonder on 17 Feb 2021
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 ...
Posted by Michael Wonder on 16 Feb 2021
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 ...
Posted by Michael Wonder on 16 Feb 2021
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. ...
Posted by Michael Wonder on 15 Feb 2021
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 ...
Posted by Michael Wonder on 12 Feb 2021
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 ...
Posted by Michael Wonder on 05 Feb 2021
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 ...
Posted by Michael Wonder on 04 Feb 2021
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 ...
Posted by Michael Wonder on 03 Feb 2021
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. ...
Posted by Michael Wonder on 02 Feb 2021
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 ...
Posted by Michael Wonder on 02 Feb 2021
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. ...
Posted by Michael Wonder on 28 Jan 2021
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 ...