FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...

Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...

BioPhorum, a global forum for biopharmaceutical industry collaboration, has formed a new working group aimed at accelerating innovation across small molecule manufacturing. 1 The Synthetic Molecule ...

FDA cleared Tregzi to improve chronic GVHD-free survival, representing a non-pharmacologic strategy to reduce chronic GVHD while supporting immune reconstitution after allogeneic transplantation.

The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain. Documentation reliability across CDMOs, ...

US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...

A second CRL was issued exclusively for unresolved CMC compliance deficiencies at the drug-substance contract manufacturer, despite no FDA concerns regarding efficacy, safety, or data sufficiency.

Cohort composition spans sterile small molecules, APIs, commercial cell-culture biologics, rare-disease drug substance, and CGT capacity across NY, NJ, IN, and NC manufacturing hubs. Eligibility ...

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient ...

Reproducible sustained delivery of a drug at a target site is one of the main themes in controlled drug-delivery systems. The most commonly used drug-delivery systems, which can release drugs longer ...

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...