Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations

Sovato secures series B funding to advance remote robotic surgery platform

The company plans to use the funds to enhance its technology and forge new strategic partnerships with surgical robotics companies

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA

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

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