FLAG Therapeutics receives rare paediatric disease designation for FLAG-003 for the treatment of children with diffuse intrinsic pontine glioma

31 January 2023 - FLAG Therapeutics announced today that FLAG-003, an investigational small molecule therapy for the treatment of diffuse intrinsic ...

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Lecanemab receives priority review status in Japan

29 January 2023 - Eisai and Biogen announced today that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β ...

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DiscGenics announces FDA regenerative medicine advanced therapy designation granted to IDCT for degenerative disc disease

26 January 2023 - DiscGenics today announced the US FDA granted regenerative medicine advanced therapy designation to injectable disc cell ...

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Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose

19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...

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Synlogic receives rare paediatric disease designation from FDA for SYNB1934 for phenylketonuria

19 January 2023 - Synlogic today announced that SYNB1934 was granted rare paediatric disease designation by the US FDA for the ...

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FDA grants rare paediatric disease status to GC Pharma’s San Filippo syndrome therapy

18 January 2023 - GC Pharma said on Wednesday that its San Filippo Syndrome type A treatment, jointly being developed ...

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FDA grants priority review for nalmefene pre-filled syringe for the treatment of known or suspected opioid overdose

18 January 2023 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...

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Forge Biologics receives PRIME designation from the EMA for novel gene therapy FBX-101 for the treatment of patients with Krabbe disease

17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...

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Orphagen Pharmaceuticals receives rare paediatric disease designation from FDA for OR-449 for the treatment of paediatric adrenocortical carcinoma

17 January 2023 - Orphagen Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for OR-449 ...

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FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma

5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...

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US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children

6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...

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bluebird bio sells second priority review voucher for $95 million

6 January 2023 - bluebird bio today announced that it has entered into a definitive agreement to sell its second ...

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Infex's novel AMR drug candidate MET-X receives FDA QIDP designation

5 January 2023 - Infex Therapeutics is pleased to announce that the US FDA has granted qualified infectious disease product ...

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UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review

6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...

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AUM Biosciences receives US FDA rare paediatric disease designation for AUM302 for treatment of neuroblastoma

5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...

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