FDA’s 2024-2025 guidances and policy signals, when read together, point to a digital-by-default oversight model built on structured data exchange, more routine remote engagement, and clearer expectations for lifecycle control of automated systems used in regulated decisions. This article translates those signals into practical steps for chemistry, manufacturing, and control, as well as quality management systems.
FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.
A framework for 2026 that moves beyond manual AI onboarding toward "zero-lag" integration for pharmaceutical manufacturing.
European biotech companies are exploring new therapeutic targets on T-cells to overcome drug resistance and improve clinical outcomes in cancer.
Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.
The FDA approves icotrokinra, the first targeted oral peptide blocking the IL-23 receptor, for moderate-to-severe plaque psoriasis with Phase III data across 2,500 patients.
Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.
SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like Alzheimer's and Parkinson's.
The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how existing therapies trigger immune response.
The FDA will evaluate tildrakizumab-asmn for psoriatic arthritis. A 2026 decision is expected based on Phase III clinical trial data.
Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses PDX models preserving tumor architecture and heterogeneity, yielding clinically relevant data for more accurate radiopharmaceutical translation.
This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities.
Rare disease drugs are forecast to exceed $400B by 2032, driven by policy shifts and pipeline growth, despite competition from large-indication products.
groninger will present innovations in equipment lifecycle programs, RTU platform flexibility, and earlier format alignment at INTERPHEX NYC, 2026.
FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers.
Japan's largest pharma event returns May 2026 with 320 sessions spanning manufacturing, quality, CMC, and digital transformation.
The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.
This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.
FDA approves leucovorin for cerebral folate deficiency, signaling how literature-based evidence can support rare disease approvals without clinical trials.
The industry is shifting toward increasingly complex, precision-driven modalities for the treatment of cancer.
FDA vaccine chief Dr. Vinay Prasad is leaving for the second time in a year amid controversies that disrupted multiple drug and vaccine development programs.
The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.
Developments across the sector highlight a period of rapid acceleration and structural modernization.
Teclistamab plus daratumumab gains FDA approval for relapsed/refractory multiple myeloma, showing 83% reduction in disease progression versus standard care.
Norgine invests £23 million in Wales site to modernize production and boost resilience for UK and European medicine supply chains.
The author discusses analytical techniques associated with cleaning and disinfection; cleanroom operation; packaging component preparation; water-for-injection production; sterile product preparation; and aseptic filling, stoppering, and sealing.
The FDA's new era of proactive enforcement uses warnings to stop misleading GLP-1 ads and ensure a fair balance of drug risks and benefits.
AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.
Sartorius' new engineered host cell line triples productivity and doubles expression titers while maintaining long-term genetic stability.
FDA granted Hernexeos accelerated approval for 1st-line HER2-mutant NSCLC after a 44-day review via the National Priority Voucher Program.
