Articles by James Chen, PharmD
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.
EU HTA Regulation Impact: What You Need to Know for 2026-2027 Market Access
Learn how the EU HTA Regulation will affect market access for drugs like XYZ, indicated for cancer treatment, in the upcoming 2026-2027 landscape.
![ANVISA Approval Immunotherapy Melanoma: Insights on [Drug Name]](/uploads/articles/anvisa-approval-novel-immunotherapy-advanced-melanoma-2024.webp)
ANVISA Approval Immunotherapy Melanoma: Insights on [Drug Name]
Explore the recent ANVISA approval of [Drug Name] for melanoma immunotherapy, highlighting its significance and potential benefits for patients.
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.
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.