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FDA General

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’s 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’s 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 MedPage Today 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

FDA EUA Novavax COVID-19 vaccine over a photo of a vial of Nuvaxovid and a syringe.

FDA OKs Updated Novavax COVID Shot

Unlike the mRNA vaccines, protein-based vaccine targets JN.1 strain

A photo of a mushroom based pain relief ointment on a tray in a wellness clinic.

Is 'Wellness' Bad News for Healthcare?

The growing industry is a double-edged sword

A photo of a lecanemab (Leqembi) downloadable patient resource.

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

A computer rendering of an Mpox virus particle.

Amid Global Emergency, FDA OKs Another Vaccine for Mpox

"All effective tools" are needed to combat mpox threat, expert says

A photo of an age check sign at the checkout counter of a convenience store.

FDA Releases Final Rule on ID Checks for Tobacco Sales

Retailers will soon have to check IDs of any tobacco product customers thought to be under 30

Photos of Shontel Brown, Ayanna Pressley, and Nydia Velazquez.

Congresswomen Press FDA on Delayed Proposal to Ban Hair-Straightening Chemicals

Agency has delayed the target date twice

FDA EUA Pemivibart (Pemgarda) over a photo of the packaging and vial of Pemgarda.

FDA Could Soon Limit Use of Only Drug for COVID Prevention

Pemivibart may have reduced activity against growing variant KP.3.1.1, agency warns

A photo of a customer making a purchase at a convenience store in Boston.

Ultraprocessed Foods Are Everywhere. How Bad Are They?

These foods make up about 60% of Americans' diets

FDA CLEARED Automated glycemic controller (SmartAdjust) over a photo of a woman wearing an Omnipod 5 device.

FDA Clears First Automated Insulin-Delivery Tech for Type 2 Diabetes

SmartAdjust technology is used in Insulet's Omnipod 5 Automated Insulin Delivery System

FDA EUA Updated 2024-2025 mRNA COVID-19 vaccines over vials of Spikevax and Comirnaty in a rubber gloved hand.

FDA OKs Updated COVID Vaccines

mRNA vaccines for 2024-2025 season will target the KP.2 subvariant

FDA APPROVED lazertinib (Lazcluze) over a computer rendering of lung cancer.

Targeted First-Line Combo Approved for EGFR-Mutated Lung Cancer

Lazertinib plus amivantamab improved PFS by about 7 months versus single-agent osimertinib

FDA MARKETING OTC syphilis screening test (First To Know Syphilis Test) over a photo of the product.

FDA OKs First Syphilis Screening Test for At-Home Use

Amid a surge in cases, FDA hopes at-home tests will help increase syphilis diagnosis, treatment

FDA APPROVED durvalumab (Imfinzi) over a computer rendering of a transparent body with lung cancer highlighted.

FDA Expands Durvalumab Label to Operable Lung Cancer

PD-L1 checkpoint inhibitor approved for use in NSCLC before and after surgery

A photo of workers inspecting microwaveable meals for defects on a production line.

FDA to Challenge Food Industry to Take Up New Sodium Targets

Agency hopes mean intake will drop to approximately 2,750 mg/day if companies comply

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