Food and Drug Administration (FDA)
NEWS
Here’s a look at who shook things up in the world of pharma and biotech this week.
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.
The DEA has reclassified GW Pharmaceutical’s cannabidiol epilepsy treatment Epidiolex as a Schedule V product, which will clear the way for commercialization within the next six weeks.
Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY) in presently in the midst of a Phase 3 study of givosiran, reporting that the drug has been successful in a clinical trial. The company hopes to use their trial data in getting givosiran approved by the U.S. Food and Drug Administration (FDA).
An experimental HIV immunotherapy treatment is showing significant promise in clinical testing. The two-drug combination is capable of suppressing HIV for months at a time, according to a study published by The Rockefeller University.
A three-year-old cancer research alliance between U.S. and Cuban scientists is bearing fruit. A Cuban-developed lung cancer treatment combined with Opdivo shows promise in treating patients.
The past few days has had a flurry of activity in the industry with leadership changes. Let’s take a look at some of those!
JOBS
IN THE PRESS