FDA grants breakthrough status to Augurex’s SPINEstat test to advance early axSpA diagnosis

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days

MedCognetics and Laurel Bridge unite to revolutionize breast cancer screening with secure AI workflow

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025

Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome

Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

Lilly buys Adverum for its phase 3-stage eye disease gene therapy

Adverum's lead program, Ixo-vec, is a Phase 3 gene therapy designed to treat vision loss associated with wet age-related macular degeneration with a single intravitreal dose

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy

Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline

The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A