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RSS FeedPosted by Michael Wonder on 14 Jun 2023
Eagle Pharmaceuticals receives FDA qualified infectious disease product and fast track designation for CAL02
14 June 2023 - With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval. ...
Posted by Michael Wonder on 12 Jun 2023
Capivasertib in combination with Faslodex granted priority review in the US for patients with advanced hormone receptor positive breast cancer
12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of ...
Posted by Michael Wonder on 02 Jun 2023
Pharming announces sale of priority review voucher
1 June 2023 - Pharming announces that it has entered into a definitive agreement with Novartis to sell its rare ...
Posted by Michael Wonder on 01 Jun 2023
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-A501 gene therapy for Danon disease
31 May 2023 - Rocket Pharmaceuticals today announced that the EMA has granted Priority Medicines (PRIME) designation to RP-A501, the ...
Posted by Michael Wonder on 27 May 2023
Iovance Biotherapeutics announces US FDA acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma
26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
Posted by Michael Wonder on 26 May 2023
Takeda and HUTCHMED announce new drug application for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review
25 May 2023 - PDUFA target action date set for 30 November 2023. ...
Posted by Michael Wonder on 23 May 2023
RegenxBio receives FDA regenerative medicine advanced therapy designation for RGX-121 gene therapy for Hunter syndrome
23 May 2023 - CAMPSIITE trial is enrolling mucopolysaccharidosis type II patients as part of a pivotal program that incorporates ...
Posted by Michael Wonder on 23 May 2023
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-L301 gene therapy for pyruvate kinase deficiency
23 May 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 17 May 2023
US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...
Posted by Michael Wonder on 16 May 2023
FDA grants SiSaf’s innovative siRNA therapy SIS-101-ADO orphan drug designation and rare paediatric disease designation for the treatment of autosomal dominant osteopetrosis
15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 04 May 2023
Humacyte’s human acellular vessel receives FDA’s regenerative medicine advanced therapy designation for urgent arterial repair following vascular trauma
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
Posted by Michael Wonder on 08 Mar 2023
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
Posted by Michael Wonder on 06 Mar 2023
FDA accepts Eisai's filing of a supplemental biologics license application and grants priority review for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease
5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023. ...
Posted by Michael Wonder on 02 Mar 2023
FDA accepts for priority review ADX-2191 new drug application for the treatment of primary vitreoretinal lymphoma
2 March 2023 - PDUFA date is 21 June 2023. ...
Posted by Michael Wonder on 28 Feb 2023
Biologics license application for lecanemab designated for priority review by China NMPA
28 February 2023 - Eisai and Biogen announced today that the biologics license application for lecanemab (brand name in the US: ...