FDA

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

Iskra Reic Takes on New Role as Executive Vice President, International for AstraZeneca

AstraZeneca has announced that Iskra Reic will now serve as the executive vice president (EVP) for international divisions, overseeing the strategic direction and fostering sustainable development throughout regions including China, Asian and Eurasian markets, Middle East & Africa, Latin America, […]

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Lilly’s Zepbound Outperforms Wegovy in Weight Loss Trial, Achieving an Average Reduction of 20.2% vs. 13.7%

Eli Lilly and Company revealed the primary results of the SURMOUNT-5 Phase 3b open-label randomized clinical trial. In this study, Zepbound (tirzepatide) achieved a 47% greater relative weight loss than Wegovy (semaglutide). On average, participants using Zepbound experienced a 20.2%

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FDA Reviews Roche’s sBLA for Columvi in Conjunction with GemOx for Relapsed or Refractory DLBCL

Roche has announced that their supplemental Biologics License Application (sBLA) for Columvi (glofitamab), when used in combination with gemcitabine and oxaliplatin (GemOx), has been accepted by the US Food and Drug Administration (FDA). This combination is intended for patients suffering

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FDA Greenlights Imfinzi for Treatment of Limited-Stage Small Cell Lung Cancer in the United States

The United States Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi (durvalumab) for adult patients diagnosed with limited-stage small cell lung cancer (LS-SCLC) whose disease remains stable following a regimen of concurrent platinum-based chemotherapy and radiotherapy. The FDA’s decision

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AIDCOC Appeals to Karnataka Government for Reinstatement of Suspended State Drugs Controller; Requests Comprehensive Investigation

The All India Drugs Control Officers’ Confederation (AIDCOC), representing the nation’s drug control officers, has expressed its alarm regarding the suspension of Karnataka’s state drugs controller. This action followed the deaths of four pregnant women from complications allegedly linked to

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Advanced Diagnostics, Genomic Testing & Mobile Health Revolutionizing Medical Services

Advanced diagnostics, genomic testing, and mobile health technologies are revolutionizing the way healthcare is delivered, especially in rural and underserved regions. These advancements promise to reduce healthcare costs and enhance health management for communities that are challenging to reach. Dinesh

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