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Results For "U.S.-Food-and-Drug-Administration"

628 News Found

Actio Biosciences launches Phase 1b/2 trial for ultra-rare pediatric epilepsy therapy
News | May 13, 2026

Actio Biosciences launches Phase 1b/2 trial for ultra-rare pediatric epilepsy therapy

The company also confirmed that ABS-1230 has been accepted into the U.S. Food and Drug Administration’s Rare Disease Evidence Principles (RDEP) process


Merck completes $5.8 billion acquisition of Terns Pharma
News | May 07, 2026

Merck completes $5.8 billion acquisition of Terns Pharma

At the center of the deal is TERN-701, a drug recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia


Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility
Biopharma | May 06, 2026

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026


FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win
News | May 02, 2026

FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants


Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA
People | May 01, 2026

Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA

Tamir brings more than 20 years of experience in the medical technology sector


Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million
R&D | April 30, 2026

Sun Pharma Advanced Research Company to sell priority review voucher for $195 Million

SPARC enters definitive agreement to monetise rare paediatric disease PRV, unlocking capital for R&D and strategic growth


Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis
Healthcare | April 29, 2026

Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis

The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder


Essilor Stellest lens positioned as key breakthrough in myopia control in India
News | April 28, 2026

Essilor Stellest lens positioned as key breakthrough in myopia control in India

The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025


EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control
Medical Device | April 28, 2026

EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs


Philips bags FDA nod for next-gen CT platform
Medical Device | April 24, 2026

Philips bags FDA nod for next-gen CT platform

Aims to boost speed & precision in patient care