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).
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).
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.
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.
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