The US Food and Drug Administration (FDA) has accepted Exelixis’ supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX) to treat two potential indications in advanced neuroendocrine tumours (NETs).
Health Canada has granted approval for Celltrion Healthcare Canada’s Steqeyma (ustekinumab injection) and Steqeyma IV (ustekinumab for injection, solution for intravenous infusion) for treating various chronic inflammatory conditions.
The US Food and Drug Administration (FDA) has approved Alpha Cognition's oral therapy, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer's disease.
LEO Pharma has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval for Anzupgo (delgocitinib cream) for adults with moderate to severe chronic hand eczema (CHE).
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for AffyImmune’s CAR T-cell therapy, AIC100, to treat recurrent anaplastic thyroid cancer (ATC).
Diamyd Medical has announced the receipt of fast track designation from the US Food and Drug Administration (FDA) for type 1 diabetes treatment, Diamyd.
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Kyverna Therapeutics’ chimeric antigen receptor (CAR) T-cell product candidate, KYV-101 for treating refractory stiff-person syndrome (SPS).
The European Commission has approved AstraZeneca's Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Alembic Pharmaceuticals has announced its tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) submitted for Ivosidenib Tablets, 250mg.
The US Food and Drug Administration (FDA) has granted fast track designation for radiotherapeutics company Full-Life Technologies’ 225Ac-FL-020 to treat metastatic castration-resistant prostate cancer (mCRPC).
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