Topic

Articles

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development. 

FDA Releases Guidance on Oncology Therapeutic Radiopharmaceuticals

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission maintains use of titanium dioxide in drug products.

In Europe, the Use of Titanium Dioxide in Drugs Will Continue

Feliza Mirasol is the science editor for 

Orphan status was granted based on Phase II data showing that treatment with rilzabrutinib reduced flares and improved markers while demonstrating consistent safety.

EMA Grants Orphan Designation to Rilzabrutinib for IgG4-Related Disease

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

FDA Commissioner Applauds Florida Restriction on 7-OH Opioids

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

FDA Grants Approval to Celltrion for Expanded Indication of Actemra Biosimilar to Treat CRS

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.

FDA Moves to Strengthen Drug Supply Chain with PreCheck Program

Mike Hennessy Jr. is the Chairman and CEO of 

Pharma manufacturing is headed toward smarter tools, deeper partnerships, and a renewed focus on compliance and quality at every stage of the product lifecycle.

The Future of Pharma: Connected, Continuous, and Compliant

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

A new nuclear magnetic resonance method reveals real-time, coordinated changes in nanoemulsion drugs, improving noninvasive analysis and regulatory evaluation.

FDA Adopts Intact NMR to Advance Nanoemulsion Drug Quality Assessment

The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.

Zenara Secures First Generic Sertraline Approval from FDA, Plus Six Months of Market Exclusivity

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial intelligence, wearables, and biomarkers in drug development and trials.

Quality Systems