Category Regulatory

Rocket Pharmaceuticals

Rocket Pharmaceuticals Advances Rare Disease Treatments With Key Conference Appearances

Rocket Pharmaceuticals to Present at Major Healthcare Conferences in Boston and Miami In the rapidly evolving landscape of genetic therapies, where precision and innovation are paramount, Rocket Pharmaceuticals, Inc. is making significant strides. The company, a fully integrated, late-stage biotechnology…

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Seaport

Seaport Therapeutics Shares Meta-Analysis Highlighting Trial Design Effects on Placebo Response in GAD

Seaport Therapeutics Presents New Meta-Analysis Examining the Impact of Clinical Trial Design Factors on Placebo Response in Generalized Anxiety Disorder Trials Seaport Therapeutics a clinical-stage therapeutics company advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the…

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GenSight Biologics

GenSight Biologics Expands Regulatory Team Across the U.S. and Europe

GenSight Biologics Bolsters Regulatory Leadership in US and Europe with Two Senior Appointments GenSight Biologics a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the strategic expansion…

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ImmunityBio

ImmunityBio Advances Regulatory Collaboration at USA-Saudi Biotech Alliance Event in Saudi Arabia

ImmunityBio Reports Productive Regulatory Engagement with Saudi Food and Drug Authority at USA-Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia ImmunityBio, Inc. a commercial stage immunotherapy company developing next generation therapies that drive immunological memory…

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iNTApharma™

Bruker Introduces iNTApharma™ Platform to Streamline Nanoparticle Characterization and QC

Bruker Introduces iNTApharma™, a Label‑Free Platform for Nanoparticle Characterization in mRNA Drug and Gene Therapy Development and QC Bruker Corporation today announced the launch of iNTApharma, a label‑free characterization platform that provides single‑particle sensitivity for the quantitative analysis of nanoscale bioparticles in native aqueous…

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Bristol Myers Squibb Launches “Change the Target. Change What’s Possible.” to Address Unmet Needs in Cardiovascular and Thromboembolic Care

Bristol Myers Squibb Launches “Change the Target. Change What’s Possible.” Campaign to Address Unmet Needs in Cardiovascular and Thromboembolic Care Bristol Myers Squibb announced today the launch of “Change the Target. Change What’s Possible.” an educational campaign developed in partnership with Johnson…

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ERLEADA® Shows 51% Lower Mortality vs Darolutamide in mCSPC (Real-World, 24-Month Analysis)

Real-World Head-to-Head Analysis Reveals 51% Lower Risk of Death in Metastatic Castration-Sensitive Prostate Cancer Patients Treated with ERLEADA® (Apalutamide) Compared to Darolutamide—Without Docetaxel—Over 24 Months Johnson & Johnson today announced new real world head-to-head evidence demonstrating that patients with metastatic castration-sensitive…

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DARZALEX

DARZALEX FASPRO® Quadruplet Approved for Transplant-Ineligible Newly Diagnosed Multiple Myeloma

DARZALEX FASPRO® quadruplet approved in U.S. for transplant-ineligible newly diagnosed multiple myeloma Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of…

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Bayer

Bayer and Vanderbilt University Medical Center Collaborate to Advance Therapies for Cardiovascular and Kidney Diseases

Bayer and Vanderbilt University Medical Center Collaborate to Advance Therapies for Cardiovascular and Kidney Diseases  Bayer and Vanderbilt University Medical Center (VUMC) today announced that they have entered a strategic five-year collaboration agreement to advance innovative therapies from target identification…

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ENHERTU

ENHERTU® + Pertuzumab Validated in EU for First-Line HER2+ Metastatic Breast Cancer

ENHERTU® Plus Pertuzumab Moves Closer to EU Approval as First-Line Therapy for HER2-Positive Metastatic Breast Cancer In a significant milestone for oncology innovation, the European Medicines Agency (EMA) has officially validated the Type II Variation marketing authorization application for ENHERTU®…

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