FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome Agency appears unswayed by mitochondria-targeting drug for rare cardioskeletal disease Oct 09, 2024
How Did Public Health Become a Public Enemy at the Supreme Court? Conservative majority is "buying into" anti-science attitudes, warns Lawrence Gostin, JD Oct 09, 2024 video
Should I Prescribe Liraglutide to a 6-Year-Old Patient With Obesity if FDA Approved? I anticipate benefits outweighing potential risks in only a select few situations Oct 06, 2024
Judge Rules Against Stem Cell Clinic Two federal court decisions now hold that fat-derived stem cell treatment is a drug Oct 02, 2024
Elevating Family Medicine Is Key for New AAFP President Jen Brull, MD, outlines her priorities for the coming year Oct 01, 2024
No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel Says Despite problematic dataset, risk/benefit profile not favorable with PD-L1 expression below 1 Sep 27, 2024
First-Ever Biologic Approved for COPD Phase III trial program showed 30% to 34% reduction in moderate or severe exacerbations Sep 27, 2024
FDA Approves First Novel Drug for Schizophrenia in Decades Xanomeline and trospium chloride (Cobenfy) has no boxed warnings Sep 27, 2024
Sickle Cell Disease Drug Pulled From Global Markets Benefits of voxelotor (Oxbryta) no longer outweigh the risks, Pfizer says Sep 26, 2024
FDA Expands Approval of Osimertinib in Lung Cancer EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy Sep 25, 2024
Second Drug OK'd for Ultra-Rare Neurodegenerative Disease FDA approves levacetylleucine (Aqneursa) for Niemann-Pick disease type C Sep 25, 2024
IG Live September 27: Court Adjourned, Healthcare Overturned Decoding recent SCOTUS decisions and their potential impact on healthcare Sep 25, 2024
Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says Data since approvals suggest benefits limited to subgroups with PD-L1 expression of at least 1% Sep 24, 2024
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
First Drug Approved for Niemann-Pick Disease Type C Arimoclomol (Miplyffa) greenlit for ultra-rare genetic disorder Sep 20, 2024
FDA Rejects NK1R Antagonist for Gastroparesis Drugmaker none-too-pleased with agency's request for additional studies Sep 19, 2024
FDA OKs New Option for Rare Immune-Mediated Vasculitis Benralizumab wins approval for eosinophilic granulomatosis with polyangiitis Sep 18, 2024
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
Eye Drop Company in FDA's Sights Once Again Agency sounds alarm that products still may contain amniotic fluid Sep 17, 2024
First Drug OK'd for Chronic Rhinosinusitis With Nasal Polyps in Adolescents Dupilumab lands expanded indication for upper airway disease Sep 17, 2024
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
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
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 OKs Software to Convert Apple AirPods Into Hearing Aids Designed for certain models, software can customize audio parameters Sep 12, 2024
FDA Warning on Hot Flash Drug Clinicians should perform liver blood tests before and during Veozah treatment Sep 12, 2024
FDA Expands Approval of IL-23 Drug to Ulcerative Colitis In trials, guselkumab more than doubled remission rates versus placebo Sep 12, 2024
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
Go After the Big E-Cigarette Makers, Not Vape Shops, House Members Tell FDA Lawmakers also queried officials about a menthol cigarette rule and labeling of milk alternatives Sep 10, 2024
FDA Advisors Question Potential Role of Novel Oral UTI Antibiotic Concerns about patient selection, antibiotic resistance dominated the discussion Sep 10, 2024
Experts Want FDA to Do More to Ensure Food Safety New food ingredients are a "complete black box," one expert says Sep 09, 2024
FDA Reviewers Voice Concerns Over Novel UTI Treatment Oral antibiotic has potential for inappropriate use, agency says Sep 06, 2024
Diversity Action Plans for Clinical Trials: Evaluating FDA's Draft Guidance A critical analysis reveals opportunities and challenges prior to finalization Sep 06, 2024
Nurse Goes Missing; Mpox on Airplanes; Warning on Pain Supplements Health news and commentary gathered by ľ¹ÏÖ±²¥ staff Sep 06, 2024
Teen Vaping Hits 10-Year Low in the U.S. Rate fell to under 6% this year, down from 7.7% in 2023 Sep 05, 2024
Nearly 2,000 Pharmaceutical Plants Are Overdue for FDA Checks After COVID Delays AP finds inspections are lacking nationally and abroad Sep 05, 2024
What to Know About Delta-8 and Other Common Vape Shop Drugs These substances are often sold through legal loopholes Sep 04, 2024
Neffy Is About to Hit Shelves: Considerations for Prescribing The first needle-free epinephrine option is encouraging, but we must proceed with caution Sep 03, 2024
FDA OKs Updated Novavax COVID Shot Unlike the mRNA vaccines, protein-based vaccine targets JN.1 strain Sep 03, 2024
If Alzheimer's Drug Ads Had More Data, Here's What Might Happen A slippery slope: emphasizing side effects could inhibit some people from accepting medicines Aug 30, 2024