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 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

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1

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 receives CE mark for novel automated high-throughput Elecsys Dengue Ag test

Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks

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

Allergan Aesthetics and Girls inspire the next generation of women leaders in STEM

Allergan Aesthetics reaffirms commitment to empowering girls through STEM mentorship and education initiatives

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

Sanofi's Q3 profit dips marginally as Dupixent sales top €4 billion

The company's net income attributable to equity holders dropped to €2.80 billion from €2.82 billion last year