Category Regulatory

Oncology

Ifinatamab Deruxtecan Receives FDA Breakthrough Therapy Designation in SCLC

Ifinatamab Deruxtecan Receives Breakthrough Therapy Designation from FDA for Pretreated Extensive-Stage Small Cell Lung Cancer The oncology research landscape took a significant step forward this week with the announcement that ifinatamab deruxtecan (I-DXd), an investigational antibody-drug conjugate (ADC), has been…

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FluMist, the Only Nasal Spray Flu Vaccine in the U.S., Now Offered Through Home Delivery

AstraZeneca Launches FluMist Home: First Nationwide At-Home Delivery Service for Needle-Free Influenza Vaccination AstraZeneca has announced the launch of FluMist Home, a pioneering direct-to-consumer initiative that will allow individuals and families in much of the United States to receive FLUMIST®…

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PADCEV + KEYTRUDA Boost Survival in Select Bladder Cancer Patients Pre- and Post-Surgery

Pfizer and Astellas Announce Landmark Phase 3 Results for PADCEV™ Plus KEYTRUDA™ in Muscle-Invasive Bladder Cancer, Marking Potential Paradigm Shift in Treatment for Cisplatin-Ineligible Patients Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura)…

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Stoke, Biogen Dose First Patient in Phase 3 EMPEROR Trial for Dravet Therapy

Stoke Therapeutics and Biogen Dose First Patient in Pivotal Phase 3 EMPEROR Study of Zorevunersen, an Investigational Disease-Modifying Therapy for Dravet Syndrome Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company pioneering RNA-based medicines to restore protein expression, and Biogen Inc.…

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Melinta

Melinta Therapeutics Acquired by CorMedix, Highlighting Portfolio Strength and Leadership

Melinta Therapeutics to Be Acquired by CorMedix in $300 Million Deal, Marking a Major Milestone in the Acute Care Pharmaceutical Sector Melinta Therapeutics, LLC (“Melinta”), a leading commercial-stage pharmaceutical company known for delivering innovative therapies for acute and life-threatening illnesses,…

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Bora Pharma

Bora Pharma Expands Midwest Site Following Upsher-Smith Split Finalization

Bora Pharmaceuticals Unveils Multi-Year Expansion of Maple Grove Site as U.S. Growth Strategy Advances Post-Upsher-Smith Split Bora Pharmaceuticals Co., Ltd. (TWSE: 6472), a leading global contract development and manufacturing organization (CDMO), has formally launched a multi-year investment plan to significantly…

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Arrowhead

Arrowhead’s Subsidiary Visirna Sells China Rights for Plozasiran to Sanofi

Arrowhead’s Subsidiary Visirna Transfers Greater China Rights to Plozasiran to Sanofi in Strategic $395 Million Deal Amid Regulatory Milestone in Hypertriglyceridemia In a move poised to reshape the therapeutic landscape for patients with severe lipid disorders in China, Arrowhead Pharmaceuticals,…

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BeOne

BeOne’s BGB-16673 Earns EMA PRIME Status for Waldenstrom’s Macroglobulinemia

BeOne Medicines Achieves Key Regulatory Milestone as EMA Grants PRIME Designation to BTK Degrader BGB-16673 for Waldenstrom’s Macroglobulinemia BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), an emerging global player in oncology therapeutics, has reached a critical milestone in…

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