Organism Attribute
FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application
FDA, Astellas, IZERVAY, geographic atrophy, age-related macular degeneration, Complete Response Letter, supplemental New Drug Application
FDA Issues Complete Response Letter to Camurus for Acromegaly Treatment Due to Third-Party Manufacturing Deficiencies
FDA, Camurus, Complete Response Letter, Acromegaly, Manufacturing Issues, Third-Party Manufacturer, CAM2029
Bavarian Nordic’s Mpox Vaccine Demonstrates Equivalent Efficacy in Teens and Adults: NIH Study
Mpox vaccine, Bavarian Nordic, MVA-BN vaccine, Teenagers, Adults, Antibody response, Safety, Efficacy, NIH study
Advancements in Pulmonary Hypertension and Interstitial Lung Disease: Emerging Therapies and Clinical Trial Designs
Pulmonary Hypertension (PH), Interstitial Lung Disease (ILD), Pulmonary Arterial Hypertension (PAH), Clinical Trials, Emerging Therapies, Pathogenesis, Phenotypes, Diagnostic Tools
FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues
Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues
Johnson & Johnson Highlights Promising Combination of TALVEY and TECVAYLI for Relapsed or Refractory Multiple Myeloma
TALVEY (talquetamab), TECVAYLI (teclistamab), Relapsed or Refractory Multiple Myeloma (RRMM), Bispecific Antibody Combination, Extramedullary Disease (EMD), High Response Rates, Durable Responses
Triple Threat: 50% of Women Delay or Skip Medical Care Due to Affordability, Access, and Negative Experiences
Women’s healthcare, Delayed medical care, Affordability issues, Access barriers, Negative healthcare experiences, Gender disparities in healthcare, Healthcare equity
FDA Raises Concerns Over Inappropriate Use of Iterum’s Antibiotic Ahead of Advisory Committee Meeting
Iterum Therapeutics, FDA, antibiotic resistance, sulopenem etzadroxil/probenecid, uncomplicated urinary tract infections (uUTIs), advisory committee meeting
Women Breaking Barriers in Drug Development: Celebrating Leadership and Innovation
Women in drug development, gender equity, STEM, pharmaceutical industry, leadership, innovation
NewAmsterdam’s Obicetrapib Hits Primary Endpoint in Phase III HeFH Study, but Falls Short of Expectations
NewAmsterdam Pharma, Obicetrapib, CETP Inhibitor, Phase III Trial, Heterozygous Familial Hypercholesterolemia (HeFH), LDL Cholesterol, HDL Cholesterol, Cardiovascular Disease