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 […]
Illumina Inc. faces yet another setback from regulatory officials regarding the company’s $8 billion acquisition of GRAIL Inc. as the European Commission provided an update.
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 Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the Marketing Authorization Application for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab).
The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
Tedros Adhanom Ghebreyesus, who has steered the global response to the COVID-19 pandemic, is on course to serve a second five-year term as head of the World Health Organization (WHO) after being the only candidate nominated by 28 countries.
CureVac NV said on Oct. 12 the company will give up on the biotechnology firm’s first-generation Covid-19 vaccine candidate and instead focus on collaborating with GSK to develop improved mRNA vaccine technology.
Moderna Inc. said on Sept. 3 the company had asked the EU drugs regulator for conditional approval of a booster shot of its Covid-19 vaccine at a 50 microgram dose.
Around 14 million people in the United States received their first dose of a Covid-19 vaccine in August, about 4 million more than in July, officials said on Aug. 31 as the government pushes inoculation as infections rise.