Familial Hypercholesterolemia Heterozygous

• CLINICAL_TRIALS trial_result · 2026-02-09
  Clinical Trial Update: Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies [Phase 3]

  This trial update reports long-term safety and tolerability data for inclisiran in participants with familial hypercholesterolemia (heterozy…

• CLINICAL_TRIALS trial_result · 2025-08-03
  Clinical Trial Update: Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH [Phase 3]

  A Phase 3b randomized, placebo-controlled, double-blind trial of Lerodalcibep in children aged 6-17 with heterozygous familial hypercholeste…

• CLINICAL_TRIALS trial_result · 2025-06-10
  Clinical Trial Update: Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia [Phase 3]

  A Phase 3 trial assessing the efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolemia has completed…

• FDA approval · 2023-04-11
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental ANDA for Colesevelam Hydrochloride, allowing the marketing of a generic Colesevelam Hydrochloride produ…

• FDA approval · 2022-02-08
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for Rosuvastatin Calcium from Zhejiang Yongtai Pharmaceutical Co., Ltd., resulting in an approved su…

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• FDA approval · 2019-05-21
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., resulting in changes to …

• FDA approval · 2017-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original application for rosuvastatin calcium (generic rosuvastatin calcium) from Quallent Pharmaceuticals Health LLC. The …

• FDA approval · 2016-07-19
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original Abbreviated New Drug Application for rosuvastatin calcium from Rising Pharma Holdings, Inc.

• CLINICAL_TRIALS trial_result · 2016-01-29
  Clinical Trial Update: Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) [Phase 3]

  Phase 3 trial update (ODYSSEY JAPAN) evaluating the efficacy and safety of alirocumab in patients with heterozygous familial hypercholestero…