Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials

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

MSD secures $700 million boost from Blackstone to advance broad-cancer ADC therapy Sac-TMT

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

Valneva’s next-gen Zika vaccine shows strong safety and immune response in phase I trial

VLA1601 is a purified and inactivated vaccine specifically designed to protect against the Zika virus

Novo Nordisk presents four new analyses on oral semaglutide 25 mg at ObesityWeek 2025

Oral semaglutide 25 mg was associated with the same weight loss efficacy in women with obesity regardless of menopausal stage, and patients reported improvements in physical function, respectively

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

Bayer's finerenone approved in India for heart failure

The expanded approval allows Kerendia to be prescribed to heart failure patients with a LVEF of 40% or more

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

Glenmark will begin distribution in November 2025