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
RedHill Biopharma Highlights Opaganib as Potential Add-On Therapy for Venetoclax-Resistant CLL

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CL...

December 16, 2025 | Tuesday | News
Greenwich LifeSciences Reports ~80% Reduction in Breast Cancer Recurrence in Phase III FLAMINGO-01 Non-HLA-A*02 Arm

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO...

December 16, 2025 | Tuesday | News
InnoCare’s Orelabrutinib Meets Primary Endpoint in Phase IIb SLE Study, Advances to Phase III

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced th...

December 15, 2025 | Monday | 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
MiNK Therapeutics Unveils MiNK-215, an IL-15–Armored FAP-Targeting CAR-iNKT With Potent Anti-Tumor Activity

MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills ...

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
China’s NMPA Clears Mabwell’s 9MW3811 for Phase II Study in Pathological Scarring

Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its novel anti‑IL‑11 monoclonal antibo...

November 12, 2025 | Wednesday | News
Gnome Sciences Identifies Cancer Drug That Prevented ALS in Preclinical Study

Gnome Sciences, a molecular pathology and translational research services company, announced a significant advance in the fight against ALS (amyotrophic ...

November 12, 2025 | Wednesday | News
Vascarta and CUNY Report Preclinical Breakthrough Demonstrating STO-1 Selectively Eliminates Glioblastoma Cells

Vascarta Inc., a healthspan focused, clinical stage biopharmaceutical company advancing safe, patient friendly therapies for pain, inflammation, and, in ...

November 11, 2025 | Tuesday | News
Repatha Reduces Risk of Heart Attack by 36% in Phase 3 VESALIUS-CV Study

Study Also Shows 36% Reduction in Risk of Heart Attack  Repatha is the First and Only PCSK9 Inhibitor to Significantly Reduce the Risk of First Hea...

November 10, 2025 | Monday | News
Merck Presents Phase 3 Data Showing Enlicitide Achieved Up to 60% LDL-C Reduction With Placebo-Like Safety

Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety pr...

November 10, 2025 | Monday | Reports
Enara Bio Expands EDAPT Platform to Include Dark Cell Surface Proteins

  Enara’s discovery of DARKFOX delivers on the vision of translating the dark genome into a new class of clinically actionable Dark Antigens ...

November 05, 2025 | Wednesday | News

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