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FDA ADCOMM elamipretide hydrochloride injection over a computer rendering of mitochondria.

Elamipretide for Barth Syndrome Survives FDA Advisory Vote

Panelists acknowledge difficulty generating stronger data in ultra-rare disease

inavolisib (Itovebi) over a computer rendering of advanced breast cancer.

PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer

Adding inavolisib to palbociclib/fulvestrant more than doubled PFS in endocrine-resistant disease

A closeup photo of a pulse oximeter on a man鈥檚 finger.

FDA's Promised Guidance on Pulse Oximeters Unlikely to End Decades of Racial Bias

Devices three times as likely to miss dangerously low blood oxygen in Black patients

FDA ADCOMM elamipretide hydrochloride injection over a computer rendering of mitochondria.

FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome

Agency appears unswayed by mitochondria-targeting drug for rare cardioskeletal disease

How Did Public Health Become a Public Enemy at the Supreme Court?

Conservative majority is "buying into" anti-science attitudes, warns Lawrence Gostin, JD

A photo of a man holding a Saxenda injection pen.

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

A photo of a healthcare worker injecting stem cells into a man鈥檚 knee.

Judge Rules Against Stem Cell Clinic

Two federal court decisions now hold that fat-derived stem cell treatment is a drug

FDA ODAC PD-(L)1 inhibitors over a computer rendering of esophageal cancer

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

FDA APPROVED dupilumab (Dupixent) over a computer rendering of a transparent body with the lung bronchi highlighted.

First-Ever Biologic Approved for COPD

Phase III trial program showed 30% to 34% reduction in moderate or severe exacerbations

FDA APPROVED anomeline and trospium chloride (Cobenfy) over a computer rendering of a brain.

FDA Approves First Novel Drug for Schizophrenia in Decades

Xanomeline and trospium chloride (Cobenfy) has no boxed warnings

A photo of a bottle of Oxbrita tablets.

Sickle Cell Disease Drug Pulled From Global Markets

Benefits of voxelotor (Oxbryta) no longer outweigh the risks, Pfizer says

FDA APPROVED osimertinib (Tagrisso) over a computer rendering of lung cancer.

FDA Expands Approval of Osimertinib in Lung Cancer

EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy

FDA APPROVED levacetylleucine (Aqneursa) over a computer rendering of mutating DNA.

Second Drug OK'd for Ultra-Rare Neurodegenerative Disease

FDA approves levacetylleucine (Aqneursa) for Niemann-Pick disease type C

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IG Live September 27: Court Adjourned, Healthcare Overturned

Decoding recent SCOTUS decisions and their potential impact on healthcare

FDA ODAC PD-(L)1 inhibitors over a computer rendering of esophageal cancer

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%

FDA APPROVED Nasal spray influenza vaccine (FluMist) over a photo of the product.

FDA OKs First Flu Vaccine for At-Home Use

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

FDA APPROVED arimoclomol (Miplyffa) over a computer rendering of a strand of DNA.

First Drug Approved for Niemann-Pick Disease Type C

Arimoclomol (Miplyffa) greenlit for ultra-rare genetic disorder

FDA CRL tradipitant (Vanda) over a computer rendering of a stomach.

FDA Rejects NK1R Antagonist for Gastroparesis

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

FDA APPROVED benralizumab (Fasenra) over a photo of vasculitis rashes on a man鈥檚 leg and foot.

FDA OKs New Option for Rare Immune-Mediated Vasculitis

Benralizumab wins approval for eosinophilic granulomatosis with polyangiitis

FDA APPROVED ribociclib (Kisqali) over a computer rendering of breast cancer.

FDA Expands Approval of Ribociclib to Early Breast Cancer

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

A photo of boxes of Regener-Eyes PRO and LITE ophthalmic solution.

Eye Drop Company in FDA's Sights Once Again

Agency sounds alarm that products still may contain amniotic fluid

FDA APPROVED Dupixent (dupilumab) over a medical illustration of nasal polyps.

First Drug OK'd for Chronic Rhinosinusitis With Nasal Polyps in Adolescents

Dupilumab lands expanded indication for upper airway disease

A photo of Boston Scientific鈥檚 Vici venous stents.

Are Regulators the Root of the Problem of Serious Device Recalls?

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

Screening After False Positive Mammograms; RSV Vaccination and Hospitalization

Also in TTHealthWatch: time from approval to reimbursement for new drugs

FDA APPROVED lebrikizumab (Ebglyss) over a photo of a woman with a severe atomic dermatitis rash on her face.

Lebrikizumab Wins FDA Approval for Eczema

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

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

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

A photo of a woman holding Apple AirPods Pro.

FDA OKs Software to Convert Apple AirPods Into Hearing Aids

Designed for certain models, software can customize audio parameters

FDA WARNING fezolinetant (Veozah) over a photo of Veozah tablet, bottle and packaging.

FDA Warning on Hot Flash Drug

Clinicians should perform liver blood tests before and during Veozah treatment

FDA approved guselkumab (Tremfya) over a computer rendering of ulcerative colitis.

FDA Expands Approval of IL-23 Drug to Ulcerative Colitis

In trials, guselkumab more than doubled remission rates versus placebo

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

FDA Reviewers Skeptical of Ocaliva for Rare Bile Duct Disease

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

A screenshot of Brian King, PhD, speaking during this hearing.

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

FDA ADCOMM sulopenem etzadroxil/probenecid (sulopenem) over a computer rendering of bacteria spilling from a bladder.

FDA Advisors Question Potential Role of Novel Oral UTI Antibiotic

Concerns about patient selection, antibiotic resistance dominated the discussion

A photo of the ingredient list on food product packaging.

Experts Want FDA to Do More to Ensure Food Safety

New food ingredients are a "complete black box," one expert says

FDA ADCOMM sulopenem etzadroxil/probenecid (sulopenem) over a computer rendering of bacteria spilling from a bladder.

FDA Reviewers Voice Concerns Over Novel UTI Treatment

Oral antibiotic has potential for inappropriate use, agency says

A photo of FDA headquarters in Silver Spring Maryland.

Diversity Action Plans for Clinical Trials: Evaluating FDA's Draft Guidance

A critical analysis reveals opportunities and challenges prior to finalization

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

Nurse Goes Missing; Mpox on Airplanes; Warning on Pain Supplements

Health news and commentary gathered by 榴莲视频 staff

A photo of an Elf Bar and Esco Bar flavored disposable vaping devices.

Teen Vaping Hits 10-Year Low in the U.S.

Rate fell to under 6% this year, down from 7.7% in 2023

A photo collage of newspaper scraps and photos.

Nearly 2,000 Pharmaceutical Plants Are Overdue for FDA Checks After COVID Delays

AP finds inspections are lacking nationally and abroad

A photo of delta-8 THC products for sale at a smoke shop in north Seattle.

What to Know About Delta-8 and Other Common Vape Shop Drugs

These substances are often sold through legal loopholes

A photo of a neffy nasal spray over a blurred photo of shelves of medication at a pharmacy.

Neffy Is About to Hit Shelves: Considerations for Prescribing

The first needle-free epinephrine option is encouraging, but we must proceed with caution

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