The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...
The Hatch Waxman Act and the Biological Price Competition and Innovation Act have incentivized efforts to improperly prolong ...
The formulation allows for greater stockpiling, with Bavarian Nordic already working with the US government to add to vaccine ...
Biotechnology firm Humacyte’s (HUMA) shares have declined since the company presented its fourth-quarter and full-year 2024 ...
Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.
That determination is made solely though the FDA approval process, which is “fundamentally separate” from any Hatch-Waxman litigation: “[A] party could win or lose in the litigation and that ...
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...
The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...
The article came just days after the FDA approved its first product ... This can be a very gradual process, as seen with robotic surgery, cryopreserved arterial allografts, and minimally invasive ...
The Food and Drug Administration (FDA) has cleared the Visby Medical Women’s Sexual Health Test for use at home to test for ...