fda drug approvals News

FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine

The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics during a relentless …

$6.4 Billion Suit Claims Bristol-Myers Delayed Cancer Drug to Avoid Shareholder Payment

Bristol Myers Squibb Co. was sued for $6.4 billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp., which the drugmaker bought in 2019. According to a complaint in Manhattan …

FDA Moving Quickly to Approve New Drugs. Is It Too Quickly?

The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer …