Food and Drug Administration (FDA)

NEWS
The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.
FDA
The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.
FDA
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
Two of the company’s largest shareholders call for the ouster of a company director at Regeneron as top executives are under fire for their enormous compensation packages.
Although the COVID-19 pandemic is waning in the U.S., there is still plenty of research and news about the disease. Here’s a look.
The new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
JOBS
IN THE PRESS