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FDA OKs First Flu Vaccine for At-Home Use

FluMist nasal spray can now be used without the help of a healthcare provider

Sep 20, 2024
FDA APPROVED Nasal spray influenza vaccine (FluMist) over a photo of the product.
First Drug Approved for Niemann-Pick Disease Type C

Arimoclomol (Miplyffa) greenlit for ultra-rare genetic disorder

Sep 20, 2024
FDA APPROVED arimoclomol (Miplyffa) over a computer rendering of a strand of DNA.
FDA Rejects NK1R Antagonist for Gastroparesis

Drugmaker none-too-pleased with agency's request for additional studies

Sep 19, 2024
FDA CRL tradipitant (Vanda) over a computer rendering of a stomach.
FDA OKs New Option for Rare Immune-Mediated Vasculitis

Benralizumab wins approval for eosinophilic granulomatosis with polyangiitis

Sep 18, 2024
FDA APPROVED benralizumab (Fasenra) over a photo of vasculitis rashes on a man’s leg and foot.
FDA Expands Approval of Ribociclib to Early Breast Cancer

Broad indication doubles the number of patients eligible for adjuvant CDK4/6 inhibition

Sep 17, 2024
FDA APPROVED ribociclib (Kisqali) over a computer rendering of breast cancer.
Eye Drop Company in FDA's Sights Once Again

Agency sounds alarm that products still may contain amniotic fluid

Sep 17, 2024
A photo of boxes of Regener-Eyes PRO and LITE ophthalmic solution.
First Drug OK'd for Chronic Rhinosinusitis With Nasal Polyps in Adolescents

Dupilumab lands expanded indication for upper airway disease

Sep 17, 2024
FDA APPROVED Dupixent (dupilumab) over a medical illustration of nasal polyps.
Are Regulators the Root of the Problem of Serious Device Recalls?

Study lays out common gaps in evidence both before and after approval

Sep 16, 2024
A photo of Boston Scientific’s Vici venous stents.
Lebrikizumab Wins FDA Approval for Eczema

38% of patients treated with IL-13 blocker achieved clear or almost-clear skin at 16 weeks

Sep 13, 2024
FDA APPROVED lebrikizumab (Ebglyss) over a photo of a woman with a severe atomic dermatitis rash on her face.
Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says

Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis

Sep 13, 2024
FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with the biliary tree highlighted.
FDA OKs Software to Convert Apple AirPods Into Hearing Aids

Designed for certain models, software can customize audio parameters

Sep 12, 2024
A photo of a woman holding Apple AirPods Pro.
FDA Warning on Hot Flash Drug

Clinicians should perform liver blood tests before and during Veozah treatment

Sep 12, 2024
FDA WARNING fezolinetant (Veozah) over a photo of Veozah tablet, bottle and packaging.
FDA Expands Approval of IL-23 Drug to Ulcerative Colitis

In trials, guselkumab more than doubled remission rates versus placebo

Sep 12, 2024
FDA approved guselkumab (Tremfya) over a computer rendering of ulcerative colitis.
FDA Reviewers Skeptical of Ocaliva for Rare Bile Duct Disease

Agency advisory panel to examine complicated efficacy data and liver safety concerns

Sep 11, 2024
FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with the biliary tree highlighted.
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