Food and Drug Administration (FDA)
NEWS
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The U.S. Food and Drug Administration (FDA) gave Bristol-Myers Squibb’s Opdivo (nivolumab) approval for metastatic small cell lung cancer (SCLC) for patients whose cancer has progressed after platinum-based chemotherapy and at least one other type of therapy.
Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration approved the company’s generic version of the EpiPen Auto-Injector.
Genentech is slashing 223 jobs at its South San Francisco headquarters, according to a Worker Adjustment and Retraining Notification posted on a California state government website. The layoffs will go into effect on Aug. 31, according to the WARN posting.
Maria Fardis, chief executive officer of Iovance Biotherapeutics, sees tumor infiltrating lymphocyte (TIL) therapies as the best immunotherapy option to treat solid cancers.
Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
As gene therapies have become reality, the U.S. government is removing some special regulations that had been set up long ago over concerns of exotic safety risks.
Biohaven Pharma, headquartered in New Haven, Conn., announced positive data from a proof-of-concept trial for its BHV-0223 in social anxiety and public speaking anxiety disorders.
ALS is a progressive neurodegenerative disease that affects neurons in the brain and the spinal cord. The disease is usually fatal within two to five years of diagnosis. While there is no cure for the disease, multiple companies are working on treatments hoping to be the first to provide a viable option for patients like Scott Hayes. There are some treatments that may provide hope for patients.
JOBS
IN THE PRESS