Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics licence application (sBLA) submitted by the former for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector (SC-AI) as a starting dose for early Alzheimer’s disease.
Opna Bio has received the US Food and Drug Administration’s (FDA) orphan drug designation for OPN-2853 (zavabresib), a bromodomain and extra-terminal motif (BET) small molecule inhibitor, to treat myelofibrosis.
iRegene Therapeutics has received regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its lead product, NouvNeu001, aimed at treating Parkinson’s disease.
Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition.
Fortress Biotech has announced that its subsidiary, Cyprium Therapeutics, received US Food and Drug Administration (FDA) approval for Zycubo (copper histidinate, earlier known as CUTX-101) as a treatment for Menkes disease.
Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics licence application (BLA) of Ebvallo (tabelecleucel).
MediLink Therapeutics has signed an exclusive licensing agreement with Roche for the development and commercialisation of YL201, an investigational antibody-drug conjugate (ADC) targeting B7H3 in various solid tumour types.
Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga for use in patients with acquired fibrinogen deficiency (AFD).
Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Takeda and Protagonist Therapeutics have jointly submitted a new drug application (NDA) seeking approval from the US Food and Drug Administration (FDA) for rusfertide to treat adults with polycythemia vera (PV).
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