GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization

New oral SERD from Roche delivers significant survival edge in early breast cancer

At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival

Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg

The product will be marketed by Dr. Reddy's Laboratories Inc.

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines

Novo Nordisk completes acquisition of Akero Therapeutics

Akero became a wholly owned subsidiary of Novo Nordisk

Lilly moves forward with $3.56-per-share acquisition of Adverum

Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older

Halozyme wins German injunction blocking Merck’s Keytruda distribution

While Merck can appeal, Halozyme said it expects the order to hold

Takeda seals $1.2 billion oncology deal with Innovent Biologics

Takeda will pay Innovent US$1.2 billion upfront, including a US$100 million equity investment in Innovent