Food and Drug Administration (FDA)
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If the new funding bill is signed by the president, the FDA will have some extra funds to support various initiatives.
Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera.
DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of Peanut-Allergic Children 4 to 11 Years of Age
History shows just how slow public health officials, the federal government, regulators and pharmaceutical companies were to respond to the emergence of HIV in the 1980s. The reasons are numerous—it was a puzzling viral disease, it first appeared in what was then a largely stigmatized patient population, gay men, and there weren’t really any existing treatments for viral diseases.
After the U.S. Food and Drug Administration (FDA) took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
On Tuesday, a U.S. Food and Drug Administration advisory panel overwhelmingly supported approval of the nasal spray treatment.
Darzalex (daratumumab) for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant.
At the same time, recognizing that use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
San Diego-based Arcturus Therapeutics announced it was reassuming 100 percent of its global rights for ARCT-810, a messenger RNA (mRNA) drug to treat OTC Deficiency. The drug previously had a 50/50 collaboration between Arcturus and Tubingen, Germany-based CureVac AG.
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