Regulation

LEO Pharma obtains positive EMA CHMP opinion for eczema treatment

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).

FDA grants RMAT designation to AffyImmune’s AIC100 for thyroid cancer

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 secures FDA fast track status for type 1 diabetes treatment

Diamyd Medical has announced the receipt of fast track designation from the US Food and Drug Administration (FDA) for type 1 diabetes treatment, Diamyd.

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.

FDA grants fast track status for Full-Life’s prostate cancer treatment

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).

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.