Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for a new monthly dosing schedule for the combination therapy Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) to treat patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
ExCellThera and its wholly owned subsidiary Cordex Biologics have received a Status 1 listing from the Neue Untersuchungs- und Behandlungsmethoden (NUB) programme in Germany for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.
Disc Medicine has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its new drug application (NDA) for bitopertin for erythropoietic protoporphyria (EPP).
Amgen has secured approval from the European Commission (EC) for Uplizna (inebilizumab) as an add-on treatment to standard therapy for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
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.
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