Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

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

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

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

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