Industry News

GSK Gets FDA Breakthrough Therapy Designation 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.

FDA Approves Pediatric Indication for Non-Surgical Severe Thermal Burn Treatment

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.

EMA Expands Indication for Bristol Myers Squibb Follicular Lymphoma Therapy

August 19, 2024

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

Nanoform and Takeda to Collaborate on Plasma-Derived Therapy Formulation

August 16, 2024

The agreement specifies that Nanoform will provide non-GMP nanomaterial to Takeda for in-vivo studies, the first results of which should be delivered by early 2025.

FDA Grants Accelerated Approval to Gilead Treatment for Primary Biliary Cholangitis

August 16, 2024

A Phase III study showed that 62% of patients given Livdelzi achieved the primary endpoint of composite biochemical response after 12 months, compared to 20% of participants taking placebo.

New Drug for Rare Disorder Hypoparathyroidism Gets FDA Approval

August 14, 2024

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

AstraZeneca Monotherapy for Gastric Cancer Gains Third Approval in China

August 14, 2024

AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

First Nasal Spray for Anaphylaxis Approved by FDA

August 13, 2024

The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

Drug Companies Encouraged by FDA to Participate in FY 2025 Site Visitation Program

August 09, 2024

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

FDA Order on OTC Monograph Drugs Containing Acetaminophen Gets Renewed Comment Period

August 08, 2024

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.