Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing

The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE

VDYNE gets FDA nod to launch pivotal US trial for tricuspid valve device

The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

Chiba University study flags allergy risk in high-binding antibody drugs

For the biopharma industry, the study strengthens the case for balancing immune-cell engagement with tolerability in antibody discovery platforms

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga

Stereotaxis bags FDA clearance for next-gen cath lab tech

Aurobindo Pharma’s CuraTeQ achieves Phase 3 success for Omalizumab biosimilar

The drug meets all primary endpoints across 608 patients in Europe and India, strengthening the company's biosimilars pipeline

HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets

Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets

Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma

The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy

Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib

ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA