Tag Archives: Approval

Approval of at-home tests releases a pandemic-fighting weapon

The Food and Drug Administration (FDA) approved inexpensive, at-home coronavirus tests for over-the-counter sales this week, adding a potentially powerful weapon to the nation’s pandemic-fighting arsenal that experts say will likely still be needed despite increasing numbers of vaccinated Americans. One of them is Michael Mina, assistant professor of epidemiology, who has called on federal… Read More »

The Latest: Johnson & Johnson single shot awaits approval

WASHINGTON – An analysis by U.S. regulators say Johnson & Johnson’s single-dose vaccine protects against COVID-19. The report Wednesday confirmed the vaccine is about 66% effective overall at preventing moderate to severe COVID-19. On Friday, a panel of experts to the Food and Drug Administration will debate if the evidence is strong enough to recommend… Read More »

Apervita’s NCQA approval helps health plans speed VBC analysis

Value-based care platform provider Apervita says it is the first company to be certified by the National Committee for Quality Assurance for electronic clinical quality measures using a clinical quality language-based engine. The company’s newly certified CQL-based engine—based on HL7 logic standards that support both eCQMs and clinical decision support—can be adopted by healthcare organizations… Read More »

Feds continue to refuse to make CBD legal without explicit FDA approval

(Photo: Adobe Stock) This week, the Food and Drug Administration (FDA) reiterated that hemp-derived cannabidiol, also known as CBD oil, is illegal to add to food, beauty or health products without prior FDA approval, or to make health claims for CBD. Despite the big farm bill President Trump signed off on this week which designates… Read More »

KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)

Print this page CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of Apadaz, an immediate release (IR)… Read More »