We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In the U.S., the Centers for Disease Control and Prevention (CDC) is reviewing whether messenger RNA-based COVID-19 vaccines are responsible for a recent outbreak of myocarditis and pericarditis in vaccinated individuals, with many cases of the conditions occurring in adolescent males. The CDC said it identified 216 cases of heart inflammation following one shot and 573 cases following a second shot. Read More
A third-party investigation of Eli Lilly’s Branchburg, N.J., facility, the site of internal whistleblower claims alleging that a quality official tampered with findings, has concluded that there is no evidence of wrongdoing at the plant. Read More
Bristol Myers Squibb (BMS) is evaluating its CAR-T therapy Breyanzi for use during earlier lines of therapy for adult lymphoma patients and said early treatment significantly improved patient outcomes in a late-stage trial. Read More
The FDA would need to see safety data from at least 3,000 trial participants to grant Emergency Use Authorization or approval for a COVID-19 vaccine for children under age 12, an agency official told members of its vaccine advisory panel yesterday. Read More
A third member of the FDA’s Peripheral and Central Nervous System Advisory Committee departed from the panel this week after the agency chose to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Read More
FDA Acting Commissioner Janet Woodcock appeared for the first time before a Senate Appropriations subcommittee Thursday to discuss the agency’s fiscal 2022 budget request, and told lawmakers that the FDA urgently needs to revamp its inspection program. Read More
The chairman of the Senate Finance Committee is leading an effort by Senate Democrats to come up with alternative legislation to two House drug pricing bills over concerns that the current House versions will not find their way through Congress. Read More
The FDA has approved Pfizer’s Prevnar 20 conjugate vaccine, which prevents invasive disease and pneumonia from 20 different strains of streptococcus. Read More