REGENXBIO has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) related to its biologics licence application (BLA) for RGX-121 (clemidsogene lanparvovec) to treat mucopolysaccharidosis II (MPS II), also called Hunter syndrome.
Apotex and Grünenthal have finalised a licensing agreement granting Apotex exclusive Canadian rights to Nebido, a long-acting injectable testosterone undecanoate therapy for male hypogonadism.
Aquestive Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for Anaphylm, a sublingual film formulation of dibutepinephrine.
Johnson & Johnson (J&J) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and recommended an indication extension for Akeega (niraparib and abiraterone acetate dual action tablet).
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition.
The US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) submitted for centanafadine, an investigational, once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) treatment.
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.
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