FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

Teva’s AUSTEDO and AUSTEDO XR demonstrate real-world improvement in patients with tardive dyskinesia

The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life

Glenmark secures China approval for Ryaltris

The approval granted with zero supplementation requests is an important milestone in Glenmark’s respiratory pipeline

Gilead’s Trodelvy falls short on progression-free survival in key breast cancer trial

While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage

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

Venus Remedies expands ASEAN presence with new drug approvals in Vietnam

Venus Remedies now has 29 active product approvals in Vietnam alone

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

AstraZeneca invests additional $136 million to expand Qingdao inhalants facility

This latest commitment brings the British pharmaceutical company’s total investment at the site to $886 million

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

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