News

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

August 05, 2025

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

The Evolving Field of Radiopharmaceuticals

August 04, 2025

Radiopharmaceuticals are moving from their standard use of treating superficial tumors into radio drug conjugates that target tumors without impacting other cells in the body.

How FDA’s ISTAND Initiative Supports Innovative Tools in Drug Discovery and Development

August 04, 2025

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.

Roche Reveals New Data from Alzheimer’s Disease Research at AAIC 2025

August 04, 2025

The company presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios at this year’s AAIC.

Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol

August 01, 2025

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

Survey: Impacts of Tariffs and Trade Policy on the Bio/pharmaceutical Industry

August 01, 2025

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

FDA Changes Opioid Pain Medication Labeling Requirements

August 01, 2025

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

FDA Seeks Scheduling Action to Control Harmful Kratom Plant Byproduct

July 31, 2025

7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

July 30, 2025

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

3 Reasons FDA Says Quality Investments Are Essential for Drug Manufacturers and Patients

July 29, 2025

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.