Caliway Submits FDA IND for Phase 2 Study of CBL-514 in Combination With Eli Lilly’s Zepbound® for Weight Management

Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical...

December 26, 2025 | Friday | News
Orchestrating Scale In Cell And Gene Therapy From Trial Complexity To Commercial Reality

As cell and gene therapies move rapidly from pioneering clinical trials into commercial healthcare systems the industry is facing a defining inflection poi...

December 25, 2025 | Thursday | Interaction
Neupulse Launches Drug-Free Wearable Offering New Hope for People Living With Tourette Syndrome

Neurotechnology company Neupulse has announced a first-of-its-kind wearable device proven to dramatically reduce the frequency and urge of tics in people l...

December 17, 2025 | Wednesday | News
The CEO Playbook For Biopharma In An Age Of Regulatory And Market Volatility

Biopharmaceutical leaders today are charting a course through unprecedented regulatory uncertainty and market turbulence. From shifting FDA and EMA approva...

December 16, 2025 | Tuesday | Analysis
Tjoapack Announces Major U.S. Expansion with New 170,000-sq-ft Pharmaceutical Packaging Facility

Tjoapack, a leading global contract packaging organization, has announced a significant strategic investment to expand its operational footprint in the U.S...

December 10, 2025 | Wednesday | News
Pfizer Phase 3 BASIS Study Shows HYMPAVZI Delivers 93% Bleed Reduction in Hemophilia With Inhibitors

-Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolesc...

December 08, 2025 | Monday | News
Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
MDA Applauds FDA Approval of Itvisma, the First Gene Replacement Therapy for a Broad SMA Population

The Muscular Dystrophy Association (MDA)  called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), ...

November 26, 2025 | Wednesday | News
AGC Biologics Partners with AAVantgarde to Advance Dual-Vector AAV Gene Therapies for Inherited Blindness

Partnership accelerates AGC Biologics' leadership in the AAV market, applying its BravoAAV™ platform to complex gene therapies for inherited blin...

November 24, 2025 | Monday | News
Purdue Pharma Reports Positive Phase 1 Results for Tinostamustine in Difficult-to-Treat Glioblastoma

Data reveals positive preliminary results for investigational agent tinostamustine as a potential first-in-class treatment for glioblastoma. -...

November 20, 2025 | Thursday | Reports
Thermo Fisher Opens Flagship United States Center in Philadelphia to Accelerate Cell & Gene Therapy Development

  New state-of-the-art facility in Philadelphia provides integrated lab and collaboration space along with tailored guidance to help move advanced th...

November 19, 2025 | Wednesday | News
Emerging EMEA: A Vital and Evolving Landscape for Biopharma Strategy, Offering a Blueprint for Agile Market Access and Global Patient Reach

  In these diverse and dynamic markets, adaptation is not a strategy; it is a prerequisite for thriving. Success requires a fundamental shift in mind...

November 19, 2025 | Wednesday | Opinion
PrognomiQ Launches ProVue Lung, a Blood-Based Test Designed for Earlier Lung Cancer Detection

Initial commercial availability begins through an Early Experience Program with Penn Highlands Healthcare and Allegheny Health Network –  Pr...

November 19, 2025 | Wednesday | News
Johnson & Johnson to Acquire Halda in $3.05 Billion Deal to Expand First-in-Class RIPTAC™ Therapeutic Platform

Halda to be acquired by Johnson & Johnson for $3.05 billion in cash Halda recently presented positive Phase 1/2 data for HLD-0915 in metastatic ca...

November 18, 2025 | Tuesday | News

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