James Chen, PharmD PharmD, BCPS

Clene's CNM-Au8 Gets FDA Green Light for Accelerated Approval Pathway in ALS Treatment

FDA confirms Clene's CNM-Au8 ALS drug can proceed via accelerated approval pathway using neurofilament light biomarker data, with NDA filing expected Q3 2026.

Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen in McCune-Albright Syndrome

Atossa Therapeutics gains FDA Rare Pediatric Disease designation for (Z)-endoxifen treating McCune-Albright syndrome, qualifying for Priority Review Voucher.

ANVISA Clinical Trial Changes Brazil: What You Need to Know

Learn about the recent changes to ANVISA's clinical trial regulations in Brazil and how they impact drug development for various medical indications.

COFEPRIS Drug Approvals 2026: What You Need to Know

Stay informed about COFEPRIS drug approvals in 2026, featuring essential insights on innovative treatments for diabetes and hypertension.

Cairn Surgical's Breast Cancer Locator System Meets Primary Endpoint in Pivotal Trial, Reduces Positive Margin Rates

Cairn Surgical announces positive pivotal trial results for its Breast Cancer Locator System, showing reduced positive margin rates compared to conventional wire localization.

Atara Biotherapeutics Receives FDA Complete Response Letter for EBVALLO Cancer Treatment, Faces Securities Class Action

Atara Biotherapeutics' EBVALLO cancer therapy receives FDA Complete Response Letter, delaying approval as company faces securities class action lawsuit deadline May 22, 2026.

Novo Nordisk's Oral Ozempic Becomes First FDA-Approved Pill GLP-1 for Type 2 Diabetes with Cardiovascular Protection

Novo Nordisk's oral Ozempic pill receives FDA approval as the first oral GLP-1 medication for type 2 diabetes with cardiovascular risk reduction benefits.

Contineum Therapeutics PIPE-791 Shows Positive Phase 1b Results for Chronic Osteoarthritis Pain

Contineum Therapeutics reports positive Phase 1b trial data for PIPE-791, a non-opioid LPA1 receptor antagonist for chronic osteoarthritis pain treatment.

AC Immune Initiates Final Cohort in Phase 1b/2 ABATE Trial for Anti-Abeta Alzheimer's Treatment

AC Immune begins final patient cohort in ABATE trial testing anti-Abeta immunotherapy for Alzheimer's disease, triggering $12M milestone payment.

FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer

FDA Advisory Committee votes 7-1 to recommend AstraZeneca's TRUQAP (capivasertib) for PTEN-deficient metastatic hormone-sensitive prostate cancer patients.

Theradaptive Receives FDA Approval for Pivotal Phase 3 Trial of OsteoAdapt SP in Spinal Fusion

Theradaptive advances OsteoAdapt SP bone regeneration therapy to pivotal Phase 3 OASIS trial for spinal fusion after FDA approval milestone.

Addex Therapeutics GABAB PAM Shows Promise for IPF-Related Chronic Cough in Preclinical Study

Addex Therapeutics reports positive preclinical data for its GABAB PAM candidate treating chronic cough in idiopathic pulmonary fibrosis patients.

Teva Acquires Emalex Biosciences for First-in-Class Tourette Syndrome Drug Ecopipam

Teva Pharmaceutical acquires Emalex Biosciences to gain access to ecopipam, a first-in-class dopamine D1 receptor antagonist for pediatric Tourette syndrome.

Laguna Biotherapeutics Receives FDA Clearance for LGNA-100 Pediatric Leukemia Trial

FDA clears Laguna's IND application for LGNA-100, a novel γδ T cell activator targeting high-risk pediatric leukemias, marking key regulatory milestone.

Expression Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for Hemophilia A Stem Cell Therapy

Expression Therapeutics gains dual FDA designations for investigational autologous stem cell therapy targeting hemophilia A, advancing to Phase 2 trials.

FDA Grants Priority Review for Gilead's Bictegravir Plus Lenacapavir HIV Treatment Combination

Gilead Sciences receives FDA priority review for novel once-daily HIV treatment combining bictegravir and lenacapavir, potentially the smallest single-tablet regimen.

Leukemia Treatment GCC: CAR-T and Blincyto Adoption Challenges 2026

This article delves into the adoption challenges of CAR-T and Blincyto in leukemia treatment within the GCC, highlighting key insights for 2026.

European Biomarker-Driven Trials: EMA Regulatory Framework & Success Rates

This article delves into the EMA's regulatory framework for biomarker-driven trials, highlighting success rates and implications for drugs like Keytruda in treating melanoma.

Biosimilars Market Analysis: US Landscape Post-Inflation Reduction Act 2026

This article analyzes the evolving landscape of the US biosimilars market for Humira post-Inflation Reduction Act 2026, highlighting key trends and implications.

Biosimilars Market Analysis: Impact of Recent FDA Approvals on US Pricing & Competition

This article analyzes how recent FDA approvals of biosimilars are reshaping pricing dynamics and competition in the US pharmaceutical market.

EU HTA Regulation Impact: Effects on Rare Disease Drug Approvals & Market Access

This article examines how the EU HTA Regulation influences the approval and market access of rare disease drugs, focusing on Zolgensma for spinal muscular atrophy.

African Clinical Trial Ethics Committees: Capacity Building & AVAREF Insights

This article delves into the vital role of African Clinical Trial Ethics Committees in capacity building, highlighting AVAREF's insights on ethical drug development.

Emergent BioSolutions Partners with Substipharm for $34.5M Japanese Encephalitis Vaccine Manufacturing Deal

Emergent BioSolutions announces $34.5M partnership with Substipharm Biologics to manufacture IMOJEV Japanese encephalitis vaccine for U.S. government distribution.

Trevi Therapeutics Schedules Q1 2026 Earnings Call for Haduvio Chronic Cough Treatment Updates

Trevi Therapeutics will report Q1 2026 financial results and provide corporate updates on Haduvio development for chronic cough treatment on May 5, 2026.