Dr. Emily Carter PhD, Chemical Engineering

Celcuity's Gedatolisib Meets Phase 3 Primary Endpoint in PIK3CA Mutant Cancer Trial

Celcuity's VIKTORIA-1 Phase 3 trial shows clinically meaningful progression-free survival improvement with gedatolisib in PIK3CA mutant patients.

FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Enters Diabetes Market

FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.

Mirum Pharmaceuticals VISTAS Study Results for Volixibat in Primary Sclerosing Cholangitis Due May 4, 2026

Mirum Pharmaceuticals will announce topline results from the VISTAS study of volixibat for primary sclerosing cholangitis treatment on May 4, 2026.

BioMarin VOXZOGO Shows Long-Term Benefits for Achondroplasia in New Clinical Data at PES 2026

BioMarin presents new VOXZOGO data showing long-term benefits on arm span, bone health and growth in children with achondroplasia at PES 2026 meeting.

Biosimilar Uptake EU: Market Impact Post-Patent Expirations & HTA Regulation

This article examines how biosimilar adoption in the EU is reshaping the market landscape for biologics like Adalimumab after patent expirations and under HTA regulations.

Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity

IMCIVREE becomes first therapy approved in both US and Europe for acquired hypothalamic obesity, targeting adults and children 4+ with hypothalamic injury.

MRM Health's MH002 Receives FDA Fast Track Designation for Ulcerative Colitis Treatment

MRM Health's lead microbiome therapeutic MH002 granted FDA Fast Track status for mild-to-moderate ulcerative colitis, accelerating development timeline.

Cadrenal Therapeutics CAD-1005 Gets FDA Guidance for Phase 3 Trial in Heparin-Induced Thrombocytopenia

Cadrenal Therapeutics receives FDA guidance to advance CAD-1005 to Phase 3 for HIT after Phase 2 showed 25% reduction in blood clots when added to standard care.

Viking Therapeutics VK2735 Phase 3 Obesity Trials Fully Enrolled as Company Reports Q1 2026 Results

Viking Therapeutics advances VK2735 obesity treatment with fully enrolled Phase 3 trials and $603M cash position, oral formulation trial expected Q4 2026.

Novo Nordisk's Denecimig Shows Significant Bleeding Reduction in Hemophilia A Phase 3 Trial Published in NEJM

Denecimig (Mim8) significantly reduced annualized bleeding rates in hemophilia A patients regardless of inhibitor status in pivotal FRONTIER2 study.

Perimeter Medical's Claire OCT+AI Receives FDA Approval for Breast Cancer Surgery Margin Assessment

Perimeter Medical's Claire OCT+AI becomes first FDA-approved AI-enabled device for real-time breast cancer margin assessment during surgery at ASBrS 2026.

Regeneron Announces Free Gene Therapy Otarmeni for Rare Hearing Loss in U.S. Government Agreement

Regeneron will provide Otarmeni gene therapy for free in the U.S. under new government agreement to lower drug costs for rare genetic hearing loss patients.

FDA Companion Diagnostic Policies: Market Evolution in Precision Oncology

This article delves into the evolving FDA companion diagnostic policies and their impact on precision oncology, focusing on drugs like Keytruda for lung cancer.

Inflation Reduction Act Drug Pricing: Impact on FDA Negotiations & Innovation 2026

The Inflation Reduction Act reshapes drug pricing strategies for diabetes treatments, influencing FDA negotiations and future pharmaceutical innovation by 2026.

China Clinical Trial Regulations: Key Insights on NMPA Reforms 2024

Discover key insights on the 2024 NMPA reforms in China, shaping clinical trial regulations and their implications for drug development in oncology and rare diseases.

Novel Immunotherapies Advanced Melanoma: EMA Approval & Phase 3 Insights

Discover the groundbreaking EMA-approved immunotherapies for advanced melanoma and insights from recent Phase 3 trials shaping future treatments.

AOP Health US Treats First Patient with Rapiblyk (Landiolol) in United States at Valley Hospital

AOP Health US achieves milestone with first Rapiblyk (landiolol) patient treatment at Valley Hospital, expanding critical care options nationwide.

FormBlends Releases 2026 Peptide Report as RFK-Era HHS Reshapes GLP-1 Therapy Access

FormBlends' 2026 State of Peptides report analyzes how RFK Jr.'s HHS and new obesity drugs from major pharma are changing GLP-1 therapy access for Americans.

Vanda Pharmaceuticals' Imsidolimab Shows Efficacy for Generalized Pustular Psoriasis in NEJM Evidence Study

Vanda Pharmaceuticals announces publication of pivotal Phase III imsidolimab study for generalized pustular psoriasis in NEJM Evidence, supporting BLA submission.

Cellenkos Receives FDA Clearance for CK0801 Phase 2 Trial in Aplastic Anemia

Cellenkos Inc. gets FDA approval to start Phase 2 trial of CK0801, an allogeneic cord blood-derived Treg therapy for transfusion-dependent aplastic anemia.

OSE Immunotherapeutics' Pegrizeprument (VEL-101) Receives FDA Orphan Drug Designation for Heart Transplant Rejection Prevention

OSE Immunotherapeutics announces FDA Orphan Drug Designation for pegrizeprument (VEL-101) to prevent heart transplant rejection, following liver designation.

SFDA expedited review programs: Impact on innovative oncology drug approvals

This article examines the impact of SFDA expedited review programs on the approval process for innovative oncology drugs, enhancing patient access to treatments.

Cancer Drug Supply Chain Security in Africa: Anti-Counterfeiting & Distribution Controls

This article delves into the challenges of ensuring secure distribution of cancer drugs in Africa, highlighting anti-counterfeiting strategies and regulatory controls.

Pulse Biosciences nPulse Cardiac Catheter Shows High Durability in Heart Rhythm 2026 Trial Data

Pulse Biosciences presents positive multicenter trial results for nPulse cardiac catheter system, showing sustained durability for atrial fibrillation treatment.