Tag Archives: 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 »

AstraZeneca, Merck's Lynparza plows ahead in ovarian cancer with $1B-plus approval, phase 3 data

The year may be winding down, but AstraZeneca and Merck’s Lynparza sure isn’t. It picked up a blockbuster new approval late Wednesday and followed up the act by posting positive phase 3 data Thursday morning. U.S. regulators green-lighted the fast-growing PARP inhibitor in BRCA-mutated ovarian cancer patients who’ve responded partially or completely to an initial… Read More »

Novartis abandons effort for U.S. approval of biosimilar rituximab

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo (Reuters) – Novartis International AG said on Friday that its Sandoz division is abandoning an effort to gain U.S. regulatory approval for a biosimilar of rituximab, a medication used… Read More »

Magicfly FDA OTC Approval Tens Unit Handheld Electronic Pulse Massager – Battery Operated Excellent Muscle Stimulator for Electrotherapy Pain Management, Upgraded Model with Backlight

Magicfly Electronic Pulse Massager with Tens Therapy, upgraded model with backlight What is it? The Electronic Pulse Massager is a Transcutaneous Electrical Nerve Stimulation or TENS UNIT. TENS units can help back and neck pain caused by trauma or continual strain. TENS therapy can help break this pain cycle by loosening the muscles and releasing… Read More »