United States Food and Drug Administration
FDA Approves Attruby (Acoramidis) for ATTR-CM, Offering New Hope for Patients with Transthyretin Cardiac Amyloidosis
Attruby, Acoramidis, FDA Approval, ATTR-CM, Transthyretin Cardiac Amyloidosis, BridgeBio Pharma, Heart Disease Treatment
Biohaven’s Taldefgrobep Alfa Misses Primary Endpoint in Phase 3 SMA Trial, Eyes FDA Discussions and Obesity Indication
Biohaven, Taldefgrobep Alfa, Spinal Muscular Atrophy (SMA), Phase 3 Trial, FDA Discussions, Obesity Indication
Trump Nominates Renowned Surgeon Martin Makary as FDA Commissioner
Martin Makary, FDA Commissioner, Donald Trump, Johns Hopkins, Surgeon, Nomination
Lexicon Pharmaceuticals Shifts Focus to Clinical Development Following Zynquista Setbacks
Lexicon Pharmaceuticals, Zynquista, FDA, Clinical Development, Restructuring, R&D Pipeline, LX9211, Sotagliflozin, LX9851
AstraZeneca Addresses Safety Concerns Over Andexxa, Discontinues Opioid Use Disorder Drug
AstraZeneca, Andexxa, FDA, Safety Concerns, Anticoagulation Reversal, Opioid Use Disorder, AZD4041
Lexicon Pharmaceuticals Shifts Focus to Clinical Development Following FDA Setbacks
Lexicon Pharmaceuticals, FDA setbacks, Clinical development focus, Commercial operations elimination, Sotagliflozin, Type 1 diabetes, Chronic kidney disease, Restructuring
UCB’s Bimzelx Receives FDA Approval for Moderate-to-Severe Hidradenitis Suppurativa, Marking Fifth Indication
Bimzelx, Bimekizumab, Hidradenitis Suppurativa, FDA Approval, IL-17A and IL-17F Inhibitor, Chronic Inflammatory Skin Disease
FDA’s Peter Marks Advocates for Open Dialogue on Vaccines Amid Controversy
FDA, Peter Marks, Vaccines, Open Dialogue, RFK Jr, HHS Nomination
FDA Panel Raises Safety Concerns Over AstraZeneca’s Anticoagulant Reversal Drug Andexxa
AstraZeneca, Andexxa, FDA panel, anticoagulant reversal drug, safety concerns, full approval
Trump Nominates Surgeon Martin Makary for FDA Commissioner Amid Criticism of COVID Mandates
Trump, FDA, Martin Makary, COVID mandates, surgeon, nomination