Drug Approval
FDA Advisory Panel Rejects PD-1 Inhibitors for Gastric and Esophageal Cancers with Low PD-L1 Expression
FDA, PD-1 inhibitors, gastric cancer, esophageal cancer, PD-L1 expression, biomarker, oncology, drug approval
FDA Advisory Committee Approves Zevra Therapeutics’ Arimoclomol for Rare Genetic Disease Treatment
Zevra Therapeutics, Arimoclomol, FDA Advisory Committee, Niemann-Pick disease, rare genetic disease, drug approval
FDA Imposes Three-Month Delay on Ascendis’ Hypoparathyroidism Treatment
Ascendis Pharma, hypoparathyroidism, FDA, drug approval, delay, three-month setback, regulatory hurdle, treatment, endocrine disorder.
How do the 12 FDA-approved gene therapies break down by medical indication
The 12 FDA-approved gene therapies cover a range of medical indications, primarily focusing on genetic disorders, cancers, and hematological conditions. Here’s a breakdown of these therapies by their medical indications: Genetic Disorders: Luxturna (voretigene neparvovec-rzyl): Approved for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, which leads to vision loss and may […]
Lykos Therapeutics’ MDMA-Assisted Therapy for PTSD: Awaiting FDA Advisory Committee Review
Lykos Therapeutics, MDMA-assisted therapy, PTSD treatment, FDA Advisory Committee, clinical trials, drug approval process.
FDA Approval Milestones: X4 Pharmaceuticals, Pfizer, and Genmab Secure Nods for Rare Disease and Cervical Cancer Treatments
FDA, X4 Pharmaceuticals, Pfizer, Genmab, rare disease, cervical cancer, drug approval, treatment, healthcare, biotechnology.