Response process
Analysts Downplay Intellia Adverse Event, but Gene Therapy Safety Remains Under Scrutiny
Intellia Therapeutics; gene therapy; safety event; adverse event; MAGNITUDE trial; liver transaminase; stock decline; ATTR-CM; gene editing; analyst response
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment
Seladelpar, Gilead Sciences, primary biliary cholangitis, PBC, European Commission, conditional marketing authorization, RESPONSE trial, ursodeoxycholic acid (UDCA)
RFK Jr. Dodges Vaccine-Autism Questions in Senate Confirmation Responses
Robert F. Kennedy Jr., HHS Secretary nomination, vaccine misinformation, autism, Senate confirmation hearings, written responses
FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter
ASH 2024: Anito-cel Demonstrates Enhanced Response Rate and Consistent Safety in Phase II Update for Relapsed/Refractory Multiple Myeloma
ASH 2024, Anito-cel, Arcellx, Relapsed/Refractory Multiple Myeloma, Phase II Update, Response Rate, Safety Profile
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
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