Approvals
The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.
Without an approval for liso-cel, Bristol Myers Squibb said the CVRs have now been terminated, are no longer eligible for payment and will no longer be allowed to trade on the New York Stock Exchange.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 29, 2020.
The U.S. Food and Drug Administration has approved several drugs and medical devices in the last week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 22, 2020.
Myovant’s oral Orgovyx beat out Abbvie’s injectable Lupron in achieving medical castration levels in patients. Here is the timeline of the approval.
The U.S. FDA is plenty busy with COVID-19 vaccine Emergency Use Authorizations this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look.
It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).
The U.S. Food and Drug Administration (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.
PRESS RELEASES