Tag Archives: approval

Ibrance Approval Expanded to Include Men With Breast Cancer

THURSDAY, April 4, 2019 — U.S. Food and Drug Administration approval of Ibrance (palbociclib) capsules has been widened to include men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or spreading (metastatic) breast cancer, the agency said Thursday in a news release. “Today we are expanding the indication for Ibrance to… 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 »