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.
Merck (known as MSD outside the US and Canada) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
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.
Dynavax Technologies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and 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).
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