Tag: approval

Japan’s Otsuka Pharma Gets FDA Approval for Alzheimer’s Agitation Drug

The U.S. Food and Drug Administration approved Otsuka Pharmaceutical’s brexpiprazole to treat agitation in patients with Alzheimer’s on Thursday, making it the first approved drug for the indication, the company said in a statement. The decision comes after an advisory panel in April voted 9–1 that the company had enough data to identify the population…


Canada’s TD Gets Regulatory Nod for $1.3 Billion Purchase of Cowen

Canada’s Toronto-Dominion Bank has received all regulatory approvals to complete its $1.3 billion acquisition of New York-based boutique investment bank Cowen Inc., the companies said on Friday. The deal is expected to close on March 1, they said. TD announced the buyout in August, building on its strategy to expand in the United States. Last…


Tesla to Win Approval for $5.5 Billion Berlin Gigafactory on Friday

BERLIN—The German state of Brandenburg has called a news conference for Friday at which it is widely expected to approve Tesla’s 5 billion euro ($5.5 billion) gigafactory near Berlin if certain conditions are met. “The approval procedure for the e-car and battery factory of the U.S. company Tesla in Gruenheide in Brandenburg is nearing completion,”…


Novavax COVID 19 Vaccine Gets Approval for Use in Canada

The Novavax COVID-19 vaccine has been approved for use in Canada. The vaccine, which is protein-based, is the first of its kind to get approval in the country. Experts say a non-mRNA vaccine could win over some vaccine-hesitant people who have still not received a dose of a COVID-19 vaccine. The U.S. company Novavax Inc….


Novavax Applies for COVID-19 Vaccine Approval in Switzerland

Novavax Inc. has submitted an application to Switzerland’s drugs regulator for the authorization of its COVID-19 vaccine in adults, the U.S. vaccine maker said on Monday. The submission is based on data from two key clinical trials in the United States and Mexico as well as in the UK that showed the vaccine was 90…


Bristol Myers Drug Wins First US Approval for Graft Versus Host Disease Prevention

Bristol Myers Squibb Co.’s Orencia on Wednesday became the first drug to win U.S. approval for the prevention of acute Graft versus Host Disease (aGvHD), a potentially fatal complication that could occur after a stem cell transplant. The Food and Drug Administration (FDA) has cleared the drug in combination with certain immunosuppressants for use in…


Tesla Seeks Court Approval of Win in Engineer’s Defamation Case

Tesla Inc. has asked a U.S. court to affirm an arbitrator’s recent decision dismissing a former engineer’s claims that the automaker fired and defamed her for raising concerns about defective floormats and contracting practices. In a petition filed in San Francisco federal court on Thursday, Tesla said an arbitrator in a Nov. 3 decision found…


S&P Global, IHS Win US Antitrust Approval for $44 Billion Deal With Conditions

WASHINGTON—Business information provider S&P Global Inc. and IHS Markit Ltd have won U.S. antitrust approval for their planned merger, on condition it sells some businesses and scraps a non-compete agreement with GasBuddy, the Justice Department said in a statement. The $44 billion deal was initially announced in November 2020. To win approval for the deal,…


UK Becomes First to Approve Antiviral Home Pill for COVID-19

Britain has become the first country to approve an antiviral COVID-19 treatment that can be taken as a pill at home. The UK national medicines regulator, the MHRA, announced on Nov. 4 that the antiviral Lagevrio (molnupiravir) had been authorised to treat mild to moderate COVID-19—in those with other risk factors, such as obesity, diabetes,…


Boy Scouts Get Conditional Approval of $850 Million Bankruptcy Deal

DOVER, Del.—A bankruptcy judge on Thursday approved a proposal by the Boy Scouts of America (BSA) to enter into an agreement that includes an $850 million fund to compensate tens of thousands of men who say they were sexually abused as youngsters by Scout leaders and others. But the judge also rejected two key provisions…