Approvals

Moderna receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against Covid-19 in US

Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.

GSK gets FDA nod for Benlysta to treat adult patients with active lupus nephritis

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) to treat adult patients with active lupus nephritis (LN) who are securing standard therapy.

Xentria announces FDA orphan drug designation for XTMAB-16 in sarcoidosis

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 gets EC orphan designation for sotatercept to treat PAH

Acceleron Pharma has secured orphan designation from the European Commission (EC) for its sotatercept to treat patients with pulmonary arterial hypertension (PAH).

Novartis gets EC nod for Leqvio to treat hypercholesterolemia or mixed dyslipidemia

Novartis has secured approval from the European Commission (EC) for its Leqvio (inclisiran) to treat adults with hypercholesterolemia or mixed dyslipidemia.

Pfizer and BioNTech celebrate historic first authorisation in US of vaccine to prevent Covid-19

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 approves Pfizer and BioNTech’s BNT162b2 vaccine for Covid-19

Canada has approved Pfizer and BioNTech’s mRNA vaccine BNT162b2 for the prevention of Covid-19.

Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC

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 announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy

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.