FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success

ADX-248, which replaces ADX-743, is being developed for the treatment of metabolic inflammation, including obesity and hypertriglyceridemia

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

GSK signs $745 million licensing agreement with Empirico for novel respiratory siRNA therapy

The deal reinforces GSK’s leadership in respiratory care and builds upon the company’s expanding COPD portfolio

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

BMS unveils new data highlighting sustained efficacy and safety of Sotyktu in psoriatic arthritis and lupus

Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions

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