Drugs

News and Updates about the regulations in Drugs and Pharma

FDA Designates AlveoGene’s Innovative Gene Therapy for Rare Neonatal Lung Disorder as an Orphan Drug

AlveoGene, a company dedicated to revolutionizing treatments for rare respiratory conditions through inhaled gene therapies, has announced that its novel therapy, AVG-002, has received Orphan Drug Designation from the US Food & Drug Administration (FDA). This recognition is for AVG-002’s […]

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FDA Recognizes Sacituzumab Tirumotecan as Breakthrough Therapy for Specific NSCLC Patients

### **Merck’s Latest Lung Cancer Therapy Receives FDA Breakthrough Designation** Merck, operating as MSD outside the USA and Canada, revealed that the U.S. Food and Drug Administration (FDA) has awarded a Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) aimed at

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Orbit Discovery and Evergreen Theragnostics Enhance research alliance to foster targeted therapy innovations

Orbit Discovery, a leader in peptide discovery services, and Evergreen Theragnostics, a pioneer in radiopharmaceuticals and precision medicine, today announced the extension of their research collaboration to develop innovative targeting peptides for radiopharmaceutical applications. This expansion builds on a previous

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Karnataka Authorities Suspend State Drugs Controller and Recall Ringer’s Lactate Solution from Hospitals Due to Quality Issues

In response to the tragic deaths of four expectant mothers who were given below-standard Ringer’s lactate solution—an intravenous fluid typically administered to restore hydration and electrolyte equilibrium—the Karnataka government has decided to suspend Dr. Umesh S., the state’s drugs controller,

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