Category Regulatory

ImmunityBio

ImmunityBio Secures Macau Approval for ANKTIVA® to Treat BCG-Unresponsive NMIBC with CIS With or Without Papillary Tumors

ImmunityBio Secures Macau SAR Authorization for ANKTIVA® in BCG-Unresponsive NMIBC with CIS With or Without Papillary Tumors ImmunityBio, today announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China has granted…

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Novartis to Acquire Pan-Mutant Selective PI3Kα Inhibitor, Bolstering Its Breast Cancer Pipeline

Novartis to Acquire Next-Generation Pan-Mutant PI3Kα Inhibitor, Enhancing Its Breast Cancer Treatment Pipeline Novartis has taken another significant step to strengthen its oncology pipeline, announcing a strategic agreement with Synnovation Therapeutics to acquire SNV4818, a next-generation pan-mutant–selective PI3Kα inhibitor. The…

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Royalty Pharma Strengthens Executive Leadership Team with Strategic Expansion

Royalty Pharma Strengthens Executive Leadership Team to Support Strategic Growth and Investment Expansion Royalty Pharma plc has announced a significant expansion of its senior leadership team, underscoring the company’s continued growth ambitions and its commitment to strengthening its position as…

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Allergan Aesthetics Introduces Skin Quality Index to Transform Skin Health Communication

Allergan Aesthetics Introduces New Skin Quality Index to Transform How Skin Health Is Measured and Communicated Allergan Aesthetics, an AbbVie company, today announced the launch of the Skin Quality Index (SQI), a unified vocabulary developed to standardize how patients and…

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Planet

Planet DDS 2026 Dental Outlook Reports More New Patients and Fewer No-Shows Across the Industry

Planet DDS 2026 Dental Outlook Shows More New Patients, Fewer No-Shows Across the Industry Planet DDS, a leading provider of cloud-based, enterprise-grade dental software solutions, announced the release of its 2026 Dental Industry Outlook, an annual benchmark report designed to help…

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Veristat

Veristat Broadens Regulatory and Clinical Services for Chinese Companies Seeking EU Market Entry

Veristat Expands Regulatory and Clinical Services to Chinese Drug and Device Companies Seeking Efficient Way to Enter European Markets Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced expanded regulatory and clinical trial services to…

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Biosciences

First Patient Dosed in Emalex Biosciences’ Expanded Access Program for Investigational Tourette Syndrome Therapy

First Patient Dosed in Emalex Biosciences’ Expanded Access Program for Investigational Tourette Syndrome Therapy Emalex Biosciences today announced that the first patient was dosed in its Expanded Access Program for ecopipam, an investigational first-in-class D1 receptor antagonist in development for…

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Enhertu Receives U.S. Priority Review for Post-Neoadjuvant Treatment of HER2-Positive Early Breast Cancer

Enhertu receives U.S. Priority Review as a post-neoadjuvant therapy for patients with early-stage HER2-positive breast cancer. AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment…

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European Commission Approves Zynyz for First-Line Treatment of Advanced Anal Cancer, Says Incyte

European Commission Approves Zynyz® (retifanlimab) as a First-Line Treatment for Patients with Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) Incyte has announced that the European Commission has granted approval for Zynyz (retifanlimab) to be used in combination with…

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Mirum

Mirum Pharmaceuticals Provides AZURE Clinical Program Update for Brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals Provides AZURE Clinical Program Update for brelovitug in Chronic Hepatitis Delta Virus Mirum Pharmaceuticals, Inc. a leading rare disease company, today announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase…

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