Food and Drug Administration (FDA)
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In a speech given at the Brookings Institution preceding the release of the U.S. Food and Drug Administration (FDA)’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb unloaded on big pharma.
Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a co-primary trial endpoint.
In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs that received it.
HIV patients have some good news this morning. The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Symtuza, the first and only complete darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1).
Recent studies in early diagnostics underline just how much focus medical technology companies are making on developing different modalities for very early cancer diagnosis. Here are just some recent examples.
Pfizer and Eli Lilly released results from its 16-week Phase III clinical trial in patients with osteoarthritis (OA) pain receiving a subcutaneous dose of tanezumab. The drug hit all three co-primary endpoints.
Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.
Shares of Siga Technologies soared more than 11 percent late Friday after the company announced that its smallpox treatment Tpoxx was approved by the U.S. Food and Drug Administration.
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