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Results For "US-FDA"

423 News Found

Pharma firms accelerate regional GLP-1 capacity to de-risk supply chains amid geopolitical tensions: GlobalData
News | April 14, 2026

Pharma firms accelerate regional GLP-1 capacity to de-risk supply chains amid geopolitical tensions: GlobalData

At the centre of this shift is Eli Lilly and Company, whose latest investments in China and Japan are helping redefine the next phase of GLP-1 supply strategy


Haemonetics gains FDA nod to expand VASCADE MVP XL for larger sheaths in heart procedures
Technology | April 12, 2026

Haemonetics gains FDA nod to expand VASCADE MVP XL for larger sheaths in heart procedures

The approval now covers procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths


Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing
News | April 10, 2026

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
Medical Device | April 10, 2026

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
Drug Approval | April 10, 2026

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
Biopharma | April 09, 2026

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
Drug Approval | April 09, 2026

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


Aurobindo Pharma’s CuraTeQ achieves Phase 3 success for Omalizumab biosimilar
Biopharma | April 07, 2026

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
News | April 07, 2026

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