FDA

News and Updates by the Food and Drugs Administration (FDA)

India’s Platform for Oncology Clinical Trials to Expedite Top-notch Drugs for Patients: Insights from Dr. Uday Saxena

Dr. Uday Saxena emphasized that the framework for conducting oncology clinical trials is maturing, thereby hastening the delivery of superior drugs to Indian patients over the coming decade. India is experiencing significant progress in cancer medication and treatment innovation, remarked

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Increased Interest in Low-Cost Respiratory Solutions Noted by Industry Professional

A growing interest in cost-effective respiratory solutions is being observed in both urban and rural sectors nationwide, spurred by an enhanced understanding of respiratory health post-Covid-19, according to a sector specialist. Suhas Shubhakaran, the co-founder of Oxymed under Karnataka-based Medequip

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Revascor Receives US FDA RMAT Designation for Pediatric Congenital Heart Disease Treatment

Mesoblast Limited, a leader in cellular medicine for inflammatory conditions, has revealed that the US FDA has awarded their allogeneic stromal cell therapy, Revascor (rexlemestrocel-L), the Regenerative Medicine Advanced Therapy (RMAT) designation. This follows promising outcomes from a trial centered

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Ministry Announces India’s Indigenous Antibiotic to Combat AMR

The Ministry of Chemicals and Fertilisers highlights the significance of nafithromycin, India’s inaugural native macrolide antibiotic, which is currently pending final authorization from the Central Drugs Standard Control Organization (CDSCO). This breakthrough represents a monumental moment in tackling antimicrobial resistance,

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Innovative Study Shows Traya’s Personalized Treatment Outperforms Leading Hair Growth Serum by Threefold

Traya, India’s pioneering health-tech company focusing on internal solutions for hair loss, released groundbreaking findings from an unprecedented clinical study comparing the effectiveness of Traya’s hair loss regimen to minoxidil, a widely used treatment, in addressing hair loss issues. This

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Centerline Biomedical Achieves FDA Approval for Innovative IOPS Guidewire Handle and Unleashes New Software Features

Centerline Biomedical Inc, a pioneering force in cardiovascular navigation and visualization technology, has achieved the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for their newly developed IOPS Guidewire Handle. This represents the latest addition to their unique and patented

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