Approvals

EMA validates Type II Variation application for ENHERTU for breast cancer treatment

Daiichi Sankyo has announced that the European Medicines Agency (EMA) validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have previously undergone a minimum of one endocrine therapy in the metastatic setting.

Sandoz’s Enzeevu secures FDA approval for nAMD treatment

The US Food and Drug Administration (FDA) has granted approval for Sandoz's Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar aimed at treating neovascular age-related macular degeneration (nAMD).

US FDA approves Purdue Pharma’s Zurnai auto-injector

The US Food and Drug Administration (FDA) has approved Purdue Pharma’s new drug application for Zurnai, the first nalmefene hydrochloride auto-injector, designed for the emergency treatment of opioid overdose.

Health Canada grants approval for Celltrion’s Steqeyma for multiple conditions

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.

FDA approves Alpha Cognition’s ZUNVEYL for Alzheimer’s treatment

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.

US FDA grants RMAT designation for Kyverna’s KYV-101

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).

EU approves AstraZeneca’s Tagrisso combined with chemotherapy for EGFRm NSCLC

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 receives tentative approval from USFDA for Ivosidenib Tablets

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.

Signet Therapeutics receives FDA approval for sigx1094 IND application

Signet Therapeutics has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for sigx1094, a potential treatment for diffuse gastric cancer (DGC).