Category Regulatory

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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Actio Biosciences Secures FDA IND Clearance and Fast Track for ABS-1230 in KCNT1 Epilepsy

Actio Biosciences Receives FDA IND Clearance and Fast Track Designation for ABS-1230 in KCNT1-Related Epilepsy, Marking Major Advancement in Pediatric Precision Medicine Actio Biosciences, a clinical-stage biotechnology company pioneering novel therapies through the lens of genetics and precision medicine, has…

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Stallergenes Greer’s Palforzia® Spotlighted on Lifetime TV’s “The Balancing Act”

Stallergenes Greer Brings National Spotlight to Peanut Allergy Awareness with Palforzia® Segment on Lifetime TV’s “The Balancing Act” Stallergenes Greer, a global biopharmaceutical company and recognized leader in allergy immunotherapy (AIT), recently announced a major milestone in its public awareness…

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