FDA Approvals

Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation

FDA approves new drug to treat HIV infection

DiscGenics Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration

DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases...

Elsevier and FDA to work on AI algorithm for drug-induced liver injury

FDA Approvals

Elsevier is working with the National Center for Toxicological Research (NCTR) at the FDA on a predictive drug-induced liver injury (DILI) algorithm. The company...

FDA Grants Hardy Diagnostics Emergency Use Authorization (EUA) for a Rapid Antibody Test Kit for COVID-19

FDA Approvals

Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced FDA EUA approval on April 24th for a new in vitro diagnostic...

Gilead’s drug remdesivir gets US FDA’s emergency use authorisation for COVID-19

FDA Approvals

Gilead was granted EUA by U.S. FDA for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to...

Vault Health Delivers Access to the First FDA EUA Approved At-Home Saliva Test for COVID-19

FDA Approvals

Vault Health, a startup specializing in healthcare for men, has turned focus to help fulfill demand for hard to get COVID-19 tests nationwide. Beginning...

Bellerophon Therapeutics Announces FDA Clears Initiation of Phase 3 Study for INOpulse Inhaled Nitric Oxide Therapy to Treat COVID-19

FDA Approvals

Bellerophon Therapeutics, Inc., a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious lung diseases, announced that the U.S. FDA accepted its...

FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

FDA Approvals

Roche announced that the US FDA has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic...

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