Pharmaceutical Industry Articles & Reports - Page 14

Examine the FDA accelerated approval of Beqalzi (sonrotoclax), the first BCL-2 inhibitor for relapsed mantle cell lymphoma, including efficacy and safety data.

Learn about the mechanics of in vivo CAR therapies using mRNA-LNP technology and explore the growing landscape of AI-driven drug discovery in biotechnology.

Review the FDA approval of tradipitant for motion sickness. Explore the pharmacology of this NK-1 receptor antagonist and its 505(b)(2) regulatory pathway.

Review Kanvas Biosciences' AI live biotherapeutics for refractory oncology. Explore how spatial microbiome mapping and KAN-001 impact cancer immunotherapy.

An in-depth analysis of Isomorphic Labs' $2.1B Series B funding. Examine the IsoDDE AI drug design engine, AlphaFold's role, and biotech industry impacts.

Learn how AI predictive tools and animal-free testing methods (NAMs) are advancing drug discovery. Read this technical review of AAPS NBC 2026 innovations.

Explore the clinical data and 505(b)(2) FDA regulatory pathway for CTx-1301 (dexmethylphenidate), a novel once-daily stimulant candidate for ADHD treatment.

Analyze the May 2026 FDA drug repurposing initiative. Learn how AI indication discovery and real-world evidence shape regulatory pathways like 505(b)(2).

Analyze the FDA's three-month PDUFA delay for subcutaneous Sarclisa. Examine its on-body injector technology, clinical data, and anti-CD38 competitors.

Takeda's 2026 transformation: 634 U.S. roles in a March 2026 WARN notice, over ¥200B in annual savings by FY2028, and how peer pharma restructurings compare.

Analyze the role of Perceptic's AI operating system in pharmaceutical R&D. Learn how unifying end-to-end data pipelines impacts drug discovery processes.

Examine the FDA's August 2026 PDUFA extension for Leqembi IQLIK. Understand the subcutaneous lecanemab clinical data, treatment costs, and infusion capacity.

A comprehensive guide to the ICH Q14 analytical procedure development guideline. Review the enhanced QbD approach, lifecycle management, and ATP integration.

A comprehensive guide to ICH Q3D elemental impurities in pharmaceuticals, detailing risk assessment methodologies, permitted daily exposures, and software.

Examine extractables and leachables (E&L) testing in pharmaceuticals. This guide reviews analytical methodologies, risk assessment, and ICH Q3E guidelines.

Examine the Bayer-Perfuse acquisition and the clinical science of PER-001, a novel endothelin receptor antagonist for glaucoma and diabetic retinopathy.

An in-depth review of pharma supplier qualification and vendor audit programs. Examines GMP regulations, risk tiering, and quality management software tools.

Explore pharmaceutical cold chain management, global GDP compliance standards, and temperature-controlled distribution software systems in this 2026 guide.

Learn about nitrosamine impurities in pharma, including 2026 FDA guidance, formation mechanisms, acceptable intake limits, and AI risk assessment tools.

A review of the ICH Q13 continuous manufacturing guideline for pharmaceuticals, covering regulatory frameworks, control strategies, and industry implementation.

Review the 2026 landscape of PBPK modeling and MIDD. This educational report analyzes Simcyp vs GastroPlus, FDA regulatory acceptance, and animal-free NAMs.

Compare leading in silico ADMET prediction software for drug discovery. Analyze feature matrices, predictive accuracy, and FDA NAM compliance across tools.

Explore the OMOP Common Data Model (CDM) and OHDSI. This guide explains how standardizing real-world data enables global federated network studies in pharma.

Examine the May 2026 GSK-SiranBio licensing deal for SA-030. Learn how this ALK7-targeting siRNA advances GSK's cardiometabolic and oligonucleotide strategy.