Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. 

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.

The World Health Organization (WHO) delayed its ongoing assessment of Russia’s Sputnik V coronavirus vaccine for emergency use because of Moscow’s invasion of Ukraine, an official from the health agency said on March 16.

The latest results from Genentech’s proposed eye disease treatments are demonstrating strong potential to help reduce treatment frequencies and deliver improved outcomes.  

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).

Nearly four months after Intellia Therapeutics – along with partner Regeneron Pharmaceuticals – reinvigorated the CRISPR space with the first-ever clinical evidence that CRISPR gene editing inside the body can be safe and effective, the asset in question was granted Orphan Drug Designation by the U.S. Food and Drug Administration.

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.

The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

U.S.-based Biomarin Pharmaceutical Inc.’s treatment for one of the most common forms of dwarfism received clearance from the European Commission, becoming the first therapy to get an approval in the region for achondroplasia.