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FDA APPROVED omalizumab (Xolair) over a photo of a syringe and vial laying on and next to a pile of peanuts

First Drug OK'd for Reducing Allergic Reactions From Multiple Foods

68% of patients who received omalizumab tolerated a single dose of peanut after 16-20 weeks

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

Tepotinib Gains Full Approval for Metastatic NSCLC

Agency converts accelerated approval for subset with MET exon 14 mutations

A screenshot of Peter Marks, MD, PhD, speaking during this hearing.

Lawmakers Clash Over COVID Vaccine Safety at House Hearing

Purpose of CDC's VAERS reporting system debated

A photo of boxes and blister packs of Paxlovid

COVID's Latest Adaptation: It Has Lulled Us to Sleep

My doctor's refusal to prescribe "just-in-case" Paxlovid speaks volumes

FDA APPROVED iloprost (Aurlumyn) over a photo of a man with severe frostbite on his fingers and thumbs.

FDA Approves First Drug for Severe Frostbite

Vasodilator iloprost significantly cut the risk of amputations in trial

FDA ADCOMM TriClip G4 system over a photo of the device

FDA Advisors Nearly All Aboard the TriClip Train for Tricuspid Regurgitation

Committee voted 13-1 that the benefits of the TEER device outweigh the risks in certain patients

FDA APPROVED irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin over an image of pancreatic cancer

New First-Line Option for Pancreatic Cancer Approved

Liposomal irinotecan-based regimen gets FDA greenlight for metastatic disease

FDA ADCOMM TriClip G4 system over a photo of the device

FDA Reviewers Skeptical on TriClip for Tricuspid Regurgitation

Tricuspid valve repair system is up for advisory committee scrutiny on Tuesday

A photo of a man wearing a Samsung Galaxy Watch

Sleep Apnea Smartwatch Feature Gets FDA Authorization

Software is first of its kind to receive agency greenlight, set to roll out this year

FDA APPROVED budesonide oral suspension (Eohilia) over a computer rendering of a body with the esophagus highlighted.

FDA Approves First Oral Option for Eosinophilic Esophagitis

Fixed-duration course of corticosteroid indicated for patients 11 years and up

A photo of nasal decongestants for sale at a CVS pharmacy.

Phenylephrine Sales Steady Before FDA Panel Called It Ineffective

But reformulation of products containing OTC "decongestant" could affect the supply chain

A microscope image of trypanosoma lewisi parasites

Treating the Tsetse's Curse

A drug called fexinidazole deserves a heart-felt shout-out

Publisher Retracts Three Abortion Studies

Two of the studies were cited by a federal judge in the case against the abortion pill

A computer rendering of a healthy liver, a fatty liver, and a cirrhotic liver

Resmetirom Poised to Become First NASH Treatment

Phase III study demonstrated drug is effective in resolving NASH and improving liver fibrosis

A photo of a woman鈥檚 hand resting on a computer mouse.

USMLE Finds Pattern of Suspicious Results From Nepal

Impacted examinees have had step 1, 2, and/or 3 examinations invalidated

FDA ADCOMM Medical device supply chain resiliency and shortages over a photo of a set of anesthesiologist instruments

FDA Panel Mulls Which Devices Are Critical in a Public Health Emergency

"If we have a thermonuclear war, all I need is a scalpel," one panel member said

A photo of a spilled container of gummy vitamins

Medicine or Candy? Let's Reevaluate the Vitamins We Offer to Kids

Children should give standard pills a try before turning to alternatives

FDA ADCOMM Medical device supply chain resiliency and shortages over a photo of a set of anesthesiologist instruments

What Exactly Is a 'Critical' Medical Device? FDA Seeks Advice on the Issue

Advisory panel to consider which devices should be on a list for shortage notifications

A close up photo of a vial of Ketamine HCL and a syringe.

Ketamine Therapy for Mental Health a 鈥榃ild West鈥� for Doctors and Patients

For some patients it's a "light at the end of the tunnel"

FDA ADCOMM Pulse oximeters over a photo of one on a man鈥檚 finger.

FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposal

But some questions arose regarding number of participants, permissible variance in measurements

FDA APPROVED Evoque tricuspid valve replacement over a computer rendering of the device.

First Transcatheter Tricuspid Regurgitation Treatment Approved

FDA greenlights system for severe cases cleared by the heart team

A computer rendering of four blisterpacks filled with miniatured fruits and vegetables where the capsules should be.

U.S. Officials Call for More Programs, Education to Improve Diets in America

More research on "gut-brain axis" is also needed

FDA ADCOMM Pulse oximeters over a photo of one on a man鈥檚 finger.

Pulse Oximeters Once Again in the Spotlight at FDA

Advisory panel to discuss how to improve device accuracy for patients with darker skin

A photo of the packaging and vial of Aduhelm.

Controversial Alzheimer's Drug Abandoned

Biogen will stop developing and selling aducanumab

FDA APPROVED FARAPULSE pulsed field ablation system over a photo of the device.

FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afib

Second catheter-based system approved for paroxysmal Afib

A photo of a Tesla MedBed Center in East Dubuque, IL

Miracle Cures: Conspiracy Theories Are Fueling a New Age of Unproven Treatments

Social media and online skepticism feed fears about traditional care

A photo of Dr. Joel Kaplan鈥檚 MegaVac penis pump.

Penis-Pump Company Chided by FDA

The agency is not enthused by the company's clitoral claims either

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

Kate Middleton Discharged; Philips to Halt Apnea Device Sales; Pet Dragon Warning

Health news and commentary from around the Web gathered by 木瓜直播 staff

A photo of FDA headquarters at White Oak Campus in Silver Spring, Maryland

How Much Do Physicians Really Know About FDA Drug and Device Regulation?

More education is clearly needed

A computer rendering of T-cells attacking growing cancer cells.

When a Revolutionary Cancer Treatment Causes Cancer

The potential benefits of CAR T-cell therapies still far outweigh the risks

A computer rendering of CAR-T immunotherapy.

CAR-T Investigation: FDA Leaders Detail Decision on Cancer Risk Warning

Post-treatment cases grow to 22 since products' initial approvals

A computer rendering of CAR T cells and a cancer cell.

FDA Calls for New Boxed Warning on All CAR-T Products

Most serious warning would alert patients, providers on potential risk for secondary malignancies

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

New FDA Boxed Warning; College Shaken by Suicides; More Get Flu Shot Than COVID Vax

Health news and commentary from around the Web gathered by 木瓜直播 staff

A photo of vials of XoGlo and XoGloPro and Amnio2X

FDA Warns Exosome Maker for Marketing Outside Its IND

Agency also raises concern about a potentially contaminated product batch

The FDA and CMS logos on two computer rendered joined puzzle pieces

The Healthcare Landscape Is Changing. Our Regulatory Practices Should Too.

Closer collaboration between FDA and CMS is the need of the hour

A photo of FDA APPROVED laying on the U.S. flag.

Physicians Don't Always Understand the FDA Approval Process, Survey Finds

Most preferred two or more randomized trials as evidence required for approval

A photo of anti-tobacco activists and their supporters during the menthol funeral in New York City.

Anti-Tobacco Activists Hold 'Menthol Funeral' in Washington

Speakers urge Biden to release long-delayed final rule banning menthol-flavored tobacco products

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

King Charles III's Surgery; COVID Timeline Doubted; FDA Approvals Hit High

Health news and commentary from around the Web gathered by 木瓜直播 staff

FDA CLEARED DermaSensor over a computer rendering of the device in use.

FDA Clears AI-Powered Non-Invasive Skin Cancer Detector

Intended for use in primary care, handheld device is first of its kind

A scanning electron microscope image of COVID particles emerging from the surface of a cell

Novel Antiviral Shortens COVID Illness in Outpatients, Reduces Viral Load

But trial did not provide data on the most clinically relevant outcomes, says expert

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