Xentria, a biopharmaceutical company focused on developing novel biologics and biosimilars to address unmet clinical needs, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its intravenous TNF-α inhibitor, XTMAB-16, for the treatment of sarcoidosis.
Acceleron Pharma has secured orphan designation from the European Commission (EC) for its sotatercept to treat patients with pulmonary arterial hypertension (PAH).
Novartis has secured approval from the European Commission (EC) for its Leqvio (inclisiran) to treat adults with hypercholesterolemia or mixed dyslipidemia.
Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.
Canada has approved Pfizer and BioNTech’s mRNA vaccine BNT162b2 for the prevention of Covid-19.
Amgen has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its sotorasib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
Neurogene, a company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, announces that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to its adeno-associated virus vector (AAV) with engineered transgene encoding the human AGA gene for patients diagnosed with aspartylglucosaminuria.
Roche announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Pfizer and BioNTech have secured temporary emergency use authorisation (EUA) from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for their Covid-19 mRNA vaccine called BNT162b2.
Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC).
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