Approvals

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).

EMA CHMP recommends marketing authorisation for Moderna’s RSV vaccine

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorisation for Moderna's mRESVIA (mRNA-1345) vaccine for adults aged 60 and above.

FDA approves Verona Pharma’s Ohtuvayre for COPD treatment

The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.

Takeda’s LIVTENCITY receives approval in Japan for CMV infections

Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare for LIVTENCITY (maribavir) for the treatment of post-transplant cytomegalovirus (CMV) infections that are refractory to existing anti-CMV therapies.