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Results For "Food-and-Drug-Administration"

1373 News Found

Shilpa Biologicals' PartnerPower promises real-time transparency in biologics development
Biopharma | June 23, 2026

Shilpa Biologicals' PartnerPower promises real-time transparency in biologics development

New digital platform provides global sponsors with live visibility into R&D, process development and GMP manufacturing operations, enhancing collaboration and decision-making


FDA advisory panel backs Moderna flu vaccine candidate for older adults
News | June 23, 2026

FDA advisory panel backs Moderna flu vaccine candidate for older adults

The backing comes as influenza remains a persistent public health burden


Alembic Pharma receives USFDA tentative approval for Binimetinib tablets
Drug Approval | June 20, 2026

Alembic Pharma receives USFDA tentative approval for Binimetinib tablets

Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market


Automated cell therapy manufacturing attracts US$1.1 Billion  across 34 funding rounds
Biopharma | June 20, 2026

Automated cell therapy manufacturing attracts US$1.1 Billion across 34 funding rounds

New Tracxn report highlights growing investor confidence in automated cell therapy production, with Cellares and Ori Biotech dominating funding and regulatory milestones


AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment
Medical Device | June 19, 2026

AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment

Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)


Lupin secures 180-day exclusivity for generic Azilsartan Medoxomil tablets in U.S. market
Drug Approval | June 18, 2026

Lupin secures 180-day exclusivity for generic Azilsartan Medoxomil tablets in U.S. market

Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million


FDA clears Dexcom’s Stelo as first OTC Continuous Glucose Monitor for kids
Medical Device | June 16, 2026

FDA clears Dexcom’s Stelo as first OTC Continuous Glucose Monitor for kids

Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes


Breakthrough approval in prostate cancer for AstraZeneca therapy
Clinical Trials | June 14, 2026

Breakthrough approval in prostate cancer for AstraZeneca therapy

The decision was driven by results from the Phase III CAPItello-281 trial,


UK approves Wegovy pill in major shift in obesity treatment options
Drug Approval | June 13, 2026

UK approves Wegovy pill in major shift in obesity treatment options

Approval is based on results from the phase 3 OASIS 4 clinical trial


FDA clears Wave Neuroscience’s AI-guided brain stimulation platform for PTSD treatment
Medical Device | June 13, 2026

FDA clears Wave Neuroscience’s AI-guided brain stimulation platform for PTSD treatment

MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms