Valneva said on April 25 that the European Medicines Agency (EMA) had asked for more data on the company’s COVID-19 vaccine, precipitating a sharp fall in the French drugmaker’s shares.
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 InflammationApprovals, Asthma, EMA, European Commission, Expanded Approval, Marketing Authorization Application (MAA), Monoclonal Antibodies, Pediatric Asthma, Regeneron Pharmaceuticals, Sanofi, Severe Asthma, Severe Pediatric Asthma, Therapeutics
Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile […]
The Janssen Pharmaceutical Companies of Johnson & Johnson announced Conditional Marketing Authorization (CMA) of RYBREVANT (amivantamab) for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.
The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The U.S. Food and Drug Administration granted accelerated approval to GlaxoSmithKline’s PD-1 checkpoint inhibitor Jemperli (dostarlimab) for a wider group of indications for adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
Swiss drugmakers Roche and Novartis each won European approval for drugs on March 30 in a sign that the rival Basel-based companies are increasingly competing for the same patients.
The European Union’s drugs regulator on March 11 approved Johnson & Johnson’s single dose Covid-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies.
AstraZeneca Plc’s cancer drug Imfinzi was approved in Europe and Britain for a spaced-out regimen in a common type of lung cancer to help reduce the frequency of hospital visits while continuing treatment.
The European Commission approved Swiss drugmaker Roche’s Xofluza to treat influenza in patients aged 12 years and older, the first new influenza antiviral for patients in almost 20 years.
The European Commission approved Aimmune Therapeutics Inc.’s Palforzia for the treatment of peanut allergy.