BioSpace News Archive

UroGen Pharma Ltd. today highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution.

Hillstream BioPharma (Nasdaq: HILS) a biotechnology company developing innovative therapeutic candidates targeting drug resistant and devastating cancers that can make a difference in patients’ lives, today announced a strategic reprioritization of its pipeline and provided a corporate update.

Cerevance today announced plans to present a poster presentation at the upcoming Alzheimer’s Association International Conference (AAIC), taking place in Amsterdam, Netherlands, July 16 – 20, 2023.

Route 92 Medical, Inc. announced the appointment of Chris Hartman to the role of Chief Commercial Officer.

Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI) announced today that on June 21, 2023, Changzhou Biowin Pharmaceutical Co., Ltd., a majority-owned subsidiary of the Company (“Biowin”), received marketing and distribution approval for its Cardiac 5-Minute Test from the Jiangsu Bureau of the National Medical Products Administration (“NMPA”), which is China’s regulatory equivalent of the U.S. Food and Drug Administration (FDA).

Medicines360 announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for treatment of Heavy Menstrual Bleeding (HMB) for up to five years in patients who choose intrauterine contraception as their method of contraception.

Acasti Pharma Inc. today announced WuXi Clinical Development, Inc. (“WuXi Clinical”) will conduct Acasti’s STRIVE-ON Phase 3 safety trial for GTX-104. GTX-104 is Acasti’s novel, injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH).

Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals US Inc. today announced that, effective immediately, CVS is covering QUVIVIQ® (daridorexant) CIV on the Performance Drug List (PDL).

The Melanoma Research Alliance announced that the RARE Registry for acral and mucosal melanoma has officially surpassed 100 patients, making it the largest registry of its kind in the world and marking an important milestone in advancing cutting-edge research for these rare and difficult-to-treat melanoma subtypes.

Motive Health, Inc., a medical technology company newly entering the direct-to-consumer health and wellness market with a focus on pain management, today announced the official launch of Motive™ Knee, the only FDA-cleared muscle stimulation device for knee pain now available without a prescription.