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

GSK signs $745 million licensing agreement with Empirico for novel respiratory siRNA therapy

The deal reinforces GSK’s leadership in respiratory care and builds upon the company’s expanding COPD portfolio

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

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

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

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

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

Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women

Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women

ANRF, in collaboration with ICMR and Gates Foundation, launches Maha MedTech Mission

With milestone-linked funding of Rs. 5–25 crore per project (and up to Rs. 50 crore in exceptional cases), the Mission will support projects that bring impactful MedTech solutions to market