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

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris

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

NATCO launches Everolimus tablets, 1 mg

Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients in kidney and liver transplantation

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

Lilly to invest $1.2 billion+ to boost oral medicine manufacturing capacity in US

Company plans to create 100 manufacturing jobs and up to 1,000 construction jobs

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