Articles tagged "FDA Approvals"
FDA Approves First True Generic Flovent HFA for Asthma Treatment
The FDA has approved the first generic version of Flovent HFA (fluticasone propionate) inhaler for asthma. Here's what healthcare providers need to know.
Lilly Launches Zepbound KwikPen: A Multi-Dose Monthly Option for Weight Management
Eli Lilly launches Zepbound KwikPen, a multi-dose device delivering a full month of tirzepatide. Here's what pharmacists need to know about access and pricing.
FDA Approves YUVEZZI: First Dual-Agent Eye Drop for Age-Related Near Vision Loss
FDA approves YUVEZZI, the first combination eye drop for presbyopia. Learn how this dual-agent treatment works and what it means for pharmacy practice.
FDA to Crackdown on Non-Approved GLP-1 Drugs
The FDA is intensifying actions against non-FDA-approved GLP-1 drugs. Learn about the implications for pharmacists and healthcare professionals.
FDA Launches PreCheck Pilot Program, Aimed at Strengthening U.S. Drug Manufacturing
FDA's new PreCheck pilot program aims to boost domestic drug manufacturing through streamlined regulatory pathways and early facility engagement.
Emergent BioSolutions Enhances NARCAN® Accessibility with New Packaging and Shelf-Life Extension
Discover Emergent BioSolutions' innovations in NARCAN® Nasal Spray packaging and shelf life to boost naloxone availability and preparation.
Roche's CT-388 Achieves 22.5% Weight Loss in Phase 2 Trial
Roche's investigational obesity drug CT-388 demonstrated 22.5% placebo-adjusted weight loss at 48 weeks in Phase 2 trial, advancing to Phase 3 studies.
Centanafadine: First Triple Reuptake Inhibitor for ADHD Nears FDA Approval
An overview of centanafadine, a novel triple reuptake inhibitor for ADHD, covering its mechanism, clinical trials, safety, FDA status, and comparison with existing therapies.
FDA Removes REMS Program for Clozapine Despite Neutropenia Risk
FDA eliminates mandatory safety program for clozapine, citing access concerns while acknowledging ongoing neutropenia risk for patients.
New Ingestible Capsule Offers Drug-Free Solution for Weight Management
FDA-cleared Epitomee capsule offers drug-free weight loss for BMI 25-40 adults. This ingestible device expands in the stomach to promote fullness without medications.
Pfizer Withdraws Oxbryta from Market Due to Safety Concerns
FDA Authorizes Apple AirPods Pro as OTC Hearing Aids with New Software Feature
FDA authorizes Apple AirPods Pro as OTC hearing aids for mild to moderate hearing loss. Learn how this software feature increases accessibility and transforms consumer tech into medical devices.
FDA Approves Self-Administered Nasal Flu Vaccine, Expanding Access and Convenience
Dexcom's Stelo: First Over-the-Counter Wearable Glucose Biosensor Enters Market
Dexcom's Stelo is the first FDA-cleared over-the-counter glucose monitor, enabling continuous tracking without prescription for prediabetic and health-conscious consumers.
FDA Approves First Nasal Spray for Anaphylaxis Treatment
FDA approves Neffy, the first epinephrine nasal spray for anaphylaxis treatment, offering a needle-free alternative to injections with comparable efficacy for emergency care.