Articles by Dr. Priya Nandakumar
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis and Blood Disorders
Incyte receives FDA approval for once-daily Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and GVHD treatment.
Purdue Pharma Shutdown: $7.4B Deal Ends OxyContin Maker's Operations
Purdue Pharma, the manufacturer of OxyContin, is ceasing operations following a $7.4 billion settlement agreement. This landmark deal aims to address the company's role in the opioid crisis and provide compensation to victims.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in Pivotal Aortic Valve Trial
Edwards Lifesciences announces 10-year COMMENCE trial results demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
Orchard Therapeutics OTL-201: Innovation Passport for MPS-IIIA
Orchard Therapeutics has secured an Innovation Passport designation from the MHRA for its investigational gene therapy, OTL-201, targeting MPS-IIIA. This marks a significant step in accelerating development and access for patients with Sanfilippo syndrome type A.
COFEPRIS Drug Approvals 2026: Regulatory Modernization and Market Impact
Explore the implications of COFEPRIS drug approvals in 2026, highlighting regulatory changes and their impact on the market for key medications like XYZ for diabetes.
FDA Scrutiny of RWE: Transforming US Drug Development & Approval
This article delves into the FDA's examination of Real-World Evidence (RWE) and its transformative impact on the approval processes for drugs like XYZ for chronic pain.
ANVISA Clinical Trial Regulations: What Foreign Pharma Must Know in 2025
Learn essential insights on ANVISA's clinical trial regulations for 2025, crucial for foreign pharmaceutical companies navigating drug approvals in Brazil.
Neurocrine Biosciences CRENESSITY Shows Sustained Benefits in Two-Year Pediatric CAH Study
CRENESSITY (crinecerfont) demonstrates durable hormone control and reduced glucocorticoid exposure in pediatric congenital adrenal hyperplasia patients.
African Medicines Agency: Shaping Regulatory Harmonization & Market Access
The African Medicines Agency is pivotal in streamlining regulatory processes and improving market access for vital medicines across Africa.
RedHill's RHB-204 Shows Comparable Efficacy to RHB-104 in Crohn's Disease MAP Treatment Development
RedHill's next-generation RHB-204 demonstrates comparable MAP-killing efficacy to RHB-104, advancing development for Crohn's disease treatment.
Summit Therapeutics Ivonescimab Shows Overall Survival Benefit in Lung Cancer, ASCO 2026 Plenary Data Expected
Summit Therapeutics reports overall survival data for ivonescimab in first-line squamous NSCLC will be featured at ASCO 2026 plenary session as late-breaking abstract.
Biosimilar Approval Pathways: ANVISA vs COFEPRIS Insights 2026
This article delves into the 2026 biosimilar approval pathways of ANVISA and COFEPRIS, focusing on their implications for monoclonal antibody therapies.
Relay Therapeutics Q1 2026 Earnings: Zovegalisib PI3Kα Inhibitor Updates Expected May 5
Relay Therapeutics announces Q1 2026 financial results May 5, featuring updates on zovegalisib, the first pan-mutant selective PI3Kα inhibitor for cancer treatment.
Neurocrine Biosciences INGREZZA Shows Clinically Meaningful Improvement in Tardive Dyskinesia Study
New research establishes clinically meaningful improvement threshold for INGREZZA (valbenazine) in tardive dyskinesia patients using TDIS scale.
FDA Accelerated Approvals Oncology: 2026 Policy Review & Zongertinib Case
This article delves into the FDA's 2026 policy review on accelerated approvals in oncology, focusing on the case of Zongertinib for lung cancer therapy.
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's Q1 2026 earnings show strong performance driven by PONLIMSI biosimilar FDA approval and olanzapine LAI NDA acceptance for schizophrenia treatment.
Rein Therapeutics LTI-03 Phase 2 Trial Enrolls 8 Patients for Idiopathic Pulmonary Fibrosis Treatment
Rein Therapeutics reports 8 patients enrolled in Phase 2 RENEW study of LTI-03 for idiopathic pulmonary fibrosis across US, Australia, and Poland sites.
Biosimilars Growth in EU: Market Forecast Post-Biologics Patent Expiry
This article analyzes the anticipated growth of biosimilars in the EU following the patent expiry of major biologics, including Humira for rheumatoid arthritis.
Cancer Care Centers of Excellence in GCC: Technology & Protocols Analysis
This article analyzes the latest technologies and treatment protocols at Cancer Care Centers of Excellence in the GCC, enhancing patient outcomes in oncology.