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FDA General

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Diversity Action Plans for Clinical Trials: Evaluating FDA's Draft Guidance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

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

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.

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.

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.

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.

FDA OKs Once-Daily Injection for Hypoparathyroidism

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

FDA ACTION midomafetamine (MDMA) over a photo of medication capsules.

FDA Rejects MDMA-Assisted Therapy for PTSD

Decision largely expected after agency advisors voted against psychedelic's safety and efficacy

FDA APPROVED epinephrine nasal spray (neffy) over a photo of the product.

FDA Approves First Emergency Allergy Nasal Spray

Neffy is a non-needle-based epinephrine treatment for anaphylaxis and other allergic reactions

FDA APPROVED carbidopa and levodopa (Crexont) over an image the substantia nigra and a neuron containing Lewy bodies.

New Extended-Release Parkinson's Drug Approved

Novel levodopa and carbidopa formulation led to more time without troublesome dyskinesia

FDA APPROVED denileukin diftitox (Lymphir) over a photo of cutaneous T-cell lymphoma.

IL-2 Receptor-Targeted Therapy Approved for Relapsed/Refractory CTCL

New iteration of denileukin diftitox led to objective responses in 36% of pretreated patients

FDA APPROVED iptacopan (Fabhalta) over a computer rendering of a transparent body with a kidney highlighted.

FDA OKs Complement Inhibitor for IgA Nephropathy

First-in-class iptacopan approved to reduce proteinuria in adults with rare progressive disease

FDA APPROVED vorasidenib (Voranigo) over a computer rendering of a brain tumor.

FDA Approves Vorasidenib for IDH-Mutant Gliomas

Treatment improved PFS by 16 months compared with placebo in INDIGO trial

A photo of packages of Plant Based Organic Burger Patties for sale in a supermarket.

Plant-based Food and Drink Labeling Is a Battlefield

Public health considerations are missing in action

A photo of a woman visiting an online pharmacy.

Prescription-Free Online Semaglutide Is Risky Business

Over 40% of pharmacy sites offering GLP-1 drug without a script are known to operate illegally

FDA ADCOMM arimoclomol over a computer rendering of a strand of DNA.

FDA Advisors Mostly Convinced Arimoclomol Works for Rare Genetic Disorder

If approved, this would be the first drug for Niemann-Pick disease type C

FDA APPROVED afamitresgene autoleucel (afami-cel, Tecelra) over a computer rendering of a tumor.

FDA Greenlights First Engineered Cell Therapy for a Solid Tumor

Afamitresgene autoleucel (Tecelra) approved for metastatic synovial sarcoma

FDA ADCOMM arimoclomol over a computer rendering of a strand of DNA.

FDA Panel to Consider Arimoclomol for Rare Genetic Disorder

This is the second time the drug has been submitted to the FDA for Niemann-Pick disease type C

FDA APPROVED daratumumab-hyaluronidase (Darzalex Faspro), bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone

FDA OKs Subcutaneous Daratumumab Plus VRd for Myeloma

Indicated for newly diagnosed patients who are eligible for stem cell transplant

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

Heavy Metal in Chocolate; Trump 'No Doubt' Hit By Bullet; FDA Cinnamon Warning Grows

Health news and commentary gathered by 麻豆传媒 staff

FDA APPROVED benzgalantamine (Zunveyl) over a computer rendering of nerve cells affected by Alzheimer鈥檚 disease.

Alzheimer's Gets New Galantamine Drug

Newly approved prodrug has dual mechanism of action to improve tolerability

A photo of a syringe resting on the lid of a glass vial.

FDA Warns of Overdoses With Compounded Semaglutide

Multi-dose vials pose complications for self-administration

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