Johnson & Johnson (J&J) has announced the US Food and Drug Administration (FDA) approval for the combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma (r/r MM).
Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a genetic medicine under investigation for treating Bcl-2-associated athanogene 3 (BAG3)-associated dilated cardiomyopathy (DCM).
Esperion Therapeutics has signed a definitive agreement to acquire Corstasis Therapeutics to expand its cardiovascular franchise with the addition of Enbumyst, a bumetanide nasal spray.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union (EU) for paediatric patients with chronic spontaneous urticaria (CSU).
BioMarin Pharmaceutical has received the US Food and Drug Administration (FDA) approval for its supplemental biologics licence application (sBLA) for Palynziq’s (pegvaliase-pqpz) use in adolescents aged 12 and above with phenylketonuria (PKU).
Beren Therapeutics has received the US Food and Drug Administration (FDA) acceptance to review its New Drug Application (NDA) for adrabetadex, an investigational therapy targeting intracellular cholesterol trafficking for infantile-onset Niemann-Pick disease type C (NPC).
AstraZeneca has secured approval in the US for Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen to treat adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the first-line setting.
Roche has obtained acceptance from the US Food and Drug Administration (FDA) for its new drug application (NDA) submitted for giredestrant, an oral therapy, along with everolimus to treat breast cancer.
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.
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