Tag Archives: approval

Promising new sickle cell disease medicine wins FDA approval

This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP) After a recent decision by the FDA a better day could be… Read More: Promising new sickle cell disease medicine wins FDA approval »

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: KemPharm Announces FDA Approval of sNDA for Two Additional Strengths… »

Medicaid work requirement in Kentucky gets second approval

The Centers for Medicare and Medicaid Services has again approved a waiver for Kentucky to impose a work requirement for able-bodied Medicaid beneficiaries as a condition to receiving the benefit. CMS previously, on January 12, approved Kentucky’s request for a 1115 demonstration project waiver that included work requirements.  However, in June, a district court judge… Read More: Medicaid work requirement in Kentucky gets second approval »

Major health industry deals said to move closer to approval

Two major healthcare deals that stand to reshape the insurance and pharmacy industries are moving toward winning antitrust approval. The approvals by a federal agency are expected to be the final step as the takeovers head toward completion, according to a person familiar with the combinations. The Department of Justice is on track to soon… Read More: Major health industry deals said to move closer to approval »