United States Food and Drug Administration
RAPT Therapeutics Announces Significant Workforce Reduction Following Clinical Hold on Zelnecirnon Trials
RAPT Therapeutics, zelnecirnon, clinical hold, workforce reduction, FDA, clinical trials, atopic dermatitis, asthma, oncology, CCR4 agonist
SEC Staff Recommends Enforcement Action Against Allarity Over Potential Federal Securities Laws Violations
Allarity Therapeutics, SEC, Enforcement Action, Federal Securities Laws, Violations, Wells Notice, FDA, Dovitinib, Stenoparib
Agenus Faces Uphill Battle After FDA Rejects Accelerated Approval for Cancer Drug Combo
Agenus, FDA, Cancer Drug Combo, BOT/BAL, Colorectal Cancer, Accelerated Approval, Stock Selloff
FDA Discourages Accelerated Approval for Agenus’ Colorectal Cancer Combination, Prompting Partnership Search
Agenus, FDA, Accelerated Approval, Colorectal Cancer, Botensilimab, Balstilimab, Immunotherapy Combination, Phase III Trial, Partnership
Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time
Orexo, OX124, FDA, Nasal Spray, Opioid Overdose, Naloxone, Human Factors Study, Technical Data
Congress Must Reauthorize FDA Program for Pediatric Rare Diseases to Save Lives
Pediatric Rare Diseases, FDA Program, Reauthorization, Creating Hope Act, Priority Review Voucher Program
FDA Rejects Novo Nordisk’s Once-Weekly Insulin Icodec for Diabetes Treatment
FDA, Novo Nordisk, Icodec, Weekly Insulin, Diabetes Treatment, Type 1 Diabetes, Type 2 Diabetes, Complete Response Letter
Arcutis Biotherapeutics Secures FDA Approval for ZORYVE Cream to Treat Atopic Dermatitis
Arcutis Biotherapeutics, ZORYVE, Atopic Dermatitis, FDA Approval, Roflumilast Cream, Steroid-Free Treatment
UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data
UniQure, Huntington’s disease, gene therapy, AMT-130, FDA, RMAT designation, Phase I/II clinical trials, neurodegenerative disorder, neurofilament light (NfL), disease progression, composite Unified Huntington’s Disease Rating Scale (cUHDRS).
FDA Approves Eli Lilly’s Alzheimer’s Drug Donanemab, Offering New Treatment Option
Alzheimer’s disease, Eli Lilly, FDA approval, donanemab, Kisunla, anti-amyloid monoclonal antibody, cognitive decline, amyloid plaques, treatment options