FDA
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018.
The U.S. FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.
In looking at companies that are shaping the future, Time Magazine selected 50 business that are leading the charge. While many tech companies lead the way, there are several pharma and life science companies that are also disrupting the future.
The U.S. Food and Drug Administration gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi, its treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Genentech snagged a new regulatory approval for its hemophilia treatment, Hemlibra. On Thursday the U.S. Food and Drug Administration approved the medication for hemophilia A patients who do not have factor VIII inhibitors.
Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai’s antiepileptic drug (AED) Fycompa (perampanel)
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for migraine prevention.
The U.S. Food and Drug Administration approved Pfizer’s once-per-day oral medication Vizimpro, a first-line treatment for patients with a rare form of lung cancer, the company announced late Thursday.
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