FDA granted Hernexeos accelerated approval for 1st-line HER2-mutant NSCLC after a 44-day review via the National Priority Voucher Program.

Novo Nordisk invests €432M ($506M) in Athlone, Ireland to boost oral glucagon-like peptide-1 manufacturing capacity for global markets by 2028.

EMA's Feb 2026 meeting resulted in the recommendation of 12 medicines, including a combined flu/COVID vaccine among the six biosimilars and six therapeutic extensions.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty pharmaceutical platform.

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic benefits for 82 million patients.

Elisabeth Gardiner, PhD, CSO of Tevard Biosciences, explains some of the challenges associated with the development of treatments for rare diseases.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before uncertainty becomes late-stage risk.

In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, AI‑driven CDMOs, and focused specialization are now critical.

Industry experts discuss the benefits of utilizing contract development and contract research organizations in drug discovery and development.

Using patent intelligence data from the FounderNest platform, Gonzalez highlights where small-molecule synthesis, formulation, and manufacturing innovation is accelerating, and what it means for pharma competition this year.

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The multi-dose pen, designed to deliver a full month’s supply, could help alleviate device supply limitations and influence future distribution strategies.

PharmTech spoke with Andrew Mitchell, associate vice president of Business Development at BioVectra, about which 2025 trends will continue to impact the pharma industry and how CDMOs can offer solutions.

This week, we highlight big news from Roche, BMS, GSK, J&J, and Lilly, as well as well as key insights from industry experts.

SCOTUS struck down IEEPA tariffs. Pharma duties under Section 232 persist as they fall outside the ruling's scope.

FDA commissioner warns US trial startup delays may cede early drug development to China, urging IND and IRB process reforms amid global competitions.

A $1 Billion Pennsylvania cell therapy site investment bolsters domestic manufacturing, creating 500 skilled biomanufacturing jobs.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

Eli Lilly & CSL seal a deal for clazakizumab partitions rights to maximize lifecycle value. CSL retains ESKD focus as Lilly prioritizes commercialization.

In part three of this four-part series regarding rare diseases, the authors examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation.

The European approval for GSK's depemokimab joins recently announced data on vaccine efficacy and progress on 4-month viral treatments.

FDA has accepted the NDA for BMS's Iberdomide, an oral agent targetting relapsed/refractory multiple myeloma.