United States Food and Drug Administration
FDA Places Clinical Hold on vTv Therapeutics’ Diabetes Drug Program
vTv Therapeutics, diabetes drug, clinical hold, FDA, cadisegliatin, type 1 diabetes
FDA Halts vTv Therapeutics’ Type-1 Diabetes Clinical Trial Due to Chromatographic Signal
vTv Therapeutics, FDA, clinical trial, type-1 diabetes, cadisegliatin, chromatographic signal, patient safety, glucokinase activator
FDA Raises Concerns Over Potential Overtreatment with AstraZeneca’s Imfinzi for NSCLC
AstraZeneca, Imfinzi, NSCLC, FDA, Overtreatment, Adcomm, Perioperative Treatment, Immune Checkpoint Inhibitors, Neoadjuvant Chemotherapy, Adjuvant Monotherapy
FDA Advisers Call for Revamp of Perioperative Lung Cancer Trials Due to Frustration with AstraZeneca’s Imfinzi Design
FDA, Imfinzi, AstraZeneca, perioperative lung cancer trials, revamp, design issues
Sun Pharma Secures FDA Approval for Leqselvi, a JAK Inhibitor for Severe Alopecia Areata
Sun Pharma, Leqselvi, FDA Approval, Alopecia Areata, JAK Inhibitor, Pfizer, Lilly, Immunology, Dermatology
EU Panel Recommends Wegovy for Preventing Cardiac Events, Following FDA Lead
Wegovy, EU panel, FDA, cardiac events, weight loss, Novo Nordisk
BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease
BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms
FDA Requests Additional Study on AstraZeneca’s Imfinzi for Lung Cancer Treatment
FDA, AstraZeneca, Imfinzi, Lung Cancer, Surgery, Adcomm
Geron Corporation Loses Chief Commercial Officer Following FDA Approval of RYTELO
Geron Corporation, Chief Commercial Officer, FDA Approval, RYTELO, Blood Cancer Treatment
FDA Issues Warning Letter to Indian CDMO Brassica for Data Falsification and Poor Hygiene Practices
FDA, Warning Letter, Brassica Pharma, Data Falsification, Poor Hygiene, Indian CDMO, CGMP Violations