Regulatory
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
COVID-19-related testimonies will continue in Congress today, with representatives from the Biotechnology Innovation Organization (BIO) expected to address the current pandemic as well as key priorities that will need to be in place in order to effectively respond to the next global viral threat.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration (FDA) has a busy two-week period coming up for drug approvals. Here’s a look.
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
PRESS RELEASES