Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

Amgen confident in US biosimilar market’s strength as sales surge 52%

J&J MedTech reports strong one-year results for shockwave peripheral IVL system in DISRUPT BTK II trial

The study demonstrated strong clinical outcomes, with 94.8 per cent of subjects remaining free from major target limb amputation at one year

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

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

Effective corrosion management demands a holistic approach: Experts

From material selection to cooling tower management, every small decision affects long-term equipment reliability

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

Advances in genetic testing, fertility preservation, and ART are reshaping reproductive care across India: Dr. Umesh N Jindal, Director, Jindal IVF

Dr. Jindal reflects on bridging accessibility gaps between urban and rural regions, the ethical and emotional aspects of family building, and how initiatives like adoption facilitation centers align with his lifelong mission to help couples realize the dream of parenthood

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