The FDA inspected Gongora USA Corp., located at 355 K St. Suite F, Chula Vista, CA, from Nov. 14 to 15, 2024, following an earlier inspection between December 2020 and January 2021.

FDA Approves Yeztugo as First Twice-Yearly Injectable HIV Prevention Option in the U.S. Clinical Trials Show Near-Perfect Efficacy With 99.9% of Pa ...

The Supreme Court rejected a challenge to the authority the federal Nuclear Regulatory Commission to approve a facility in Texas to store spent fuel.

The Food and Drug Administration approved a new, highly effective HIV-prevention medication. The drug nearly eliminated HIV’s spread among people given an injection twice a year in clinical ...

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo ® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as ...

The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Gilead said the drug will be ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Researchers from the George Washington University have uncovered promising evidence in an animal study that shows setmelanotide, an FDA-approved medication for a rare genetic obesity disorder, may ...

PolyPid secures $26.7 million funding, extending runway past FDA approval for D-PLEX₁₀₀, which showed promising Phase 3 trial results. PolyPid Ltd. has announced that it has secured $26.7 ...

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck ...

US regulators delayed their decision on whether to approve the first pill taken on demand for a rare, inherited swelling disorder due to a “heavy workload and limited resources,” a biotech ...