Category Regulatory

BioNTech Showcases Promising Late-Stage Lung Cancer Portfolio with New Clinical Data at ELCC 2026

BioNTech presents new ELCC 2026 data underscoring the strength and differentiation of its late-stage lung cancer pipeline BioNTech has announced that it will showcase new clinical data from its expanding lung cancer pipeline at the European Lung Cancer Congress 2026,…

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Celltrion

Celltrion Unveils KRW 1.2 Trillion Expansion of Songdo Drug Substance Facilities, Boosting Total Capacity to 570,000 Liters

Celltrion unveils KRW 1.2 trillion Songdo expansion, boosting DS production capacity by 180,000L to a total of 570,000L Celltrion has unveiled an ambitious and far-reaching investment strategy aimed at significantly expanding its global manufacturing footprint, reinforcing its position in the…

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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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