Industry News

AstraZeneca Invests Additional $135 Million in Swedish Biologics Facility

September 04, 2024

This is the company’s largest single investment in the Sweden Biomanufacturing Center, in Södertälje, which opened in 2021.

Responding to Mpox

September 03, 2024

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

RedHill Granted FDA Orphan Drug Designation for Neuroblastoma Treatment

August 26, 2024

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

Borealis Biosciences Created by Novartis and Versant to Develop Kidney Disease Treatments

August 23, 2024

The collaboration builds on Novartis’ acquisition of Chinook Therapeutics just over a year ago.

Updated 2024–2025 mRNA COVID-19 Vaccines Approved and Granted EUA by FDA

August 22, 2024

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

Bristol Myers Squibb Application for Unresectable Hepatocellular Carcinoma First-Line Treatment Accepted by FDA

August 21, 2024

The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma.

FDA Grants Breakthrough Therapy Designation to GSK for Small-Cell Lung Cancer Treatment

August 20, 2024

Approximately 15% of all lung cancers diagnosed in the US are of the small-cell variety, and of those, 70% are considered extensive-stage.

Bristol Myers Squibb Follicular Lymphoma Therapy Gets Expanded EMA Indication

August 20, 2024

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

Non-Surgical Severe Thermal Burn Treatment Gets FDA Approval for Pediatric Indication

August 19, 2024

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

FDA Approves New Drug for Rare Disorder Hypoparathyroidism

August 16, 2024

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH.