Glenmark Pharmaceuticals USA to launch 8.4% Sodium Bicarbonate Injection USP, 50 mEq Single-Dose Vial

Glenmark will begin distribution in November 2025

Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde

Roche’s Gazyva shows breakthrough efficacy in phase III lupus study

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response

Industry leaders call for a new era of collaboration, innovation, and self-reliance

Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence

Cosmo Plastech expands rigid packaging solutions for pharma industry with PET sheets

PET sheets are widely recognised for their superior clarity, strength, and barrier properties

BMS’ Cobenfy sees steady start, eyes stronger growth ahead

Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter

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