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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Are Regulators the Root of the Problem of Serious Device Recalls?

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

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Nurse Goes Missing; Mpox on Airplanes; Warning on Pain Supplements

Health news and commentary gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Is 'Wellness' Bad News for Healthcare?

The growing industry is a double-edged sword

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

FDA APPROVED axatilimab-csfr (Niktimvo) over a computer rendering of antibodies.

<乌鸦传媒>Novel Agent for Chronic GVHD Wins FDA Approval

Axatilimab achieved a 75% response rate in patients with previously treated chronic GVHD

FDA APPROVED seladelpar (Livdelzi) over a rendering of a transparent body with the gallbladder and bile duct highlighted.

<乌鸦传媒>FDA OKs New Option for Primary Biliary Cholangitis

Seladelpar improved biochemical response, ALP normalization versus placebo in phase III trial

A photo of a nurse drawing blood from a male patient.

<乌鸦传媒>Blood Test for Colon Cancer: Panacea or Hype?

This newly approved testing modality brings challenges and opportunities

FDA APPROVED nemolizumab (Nemluvio) over a photo of prurigo skin manifestations.

<乌鸦传媒>IL-31 Drug for Itchy Nodular Skin Disease Gets Thumbs Up From FDA

Nemolizumab significantly improved itch, nodules, and sleep disturbance at 16 weeks

FDA APPROVED palopegteriparatide (Yorvipath) over a computer rendering of the thyroid gland.

<乌鸦传媒>FDA OKs Once-Daily Injection for Hypoparathyroidism

Palopegteriparatide will be the only drug targeting underlying cause of rare endocrine disorder

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