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FDA General

A photo of a female virologist marking samples with a marker in a laboratory.

<乌鸦传媒>Banning Gain-of-Function Research Would Do Far More Harm Than Good

A House-passed bill could stifle the potential for revolutionary medical advancements

FDA APPROVED nivolumab (Opdivo) over a computer rendering of bladder cancer.

<乌鸦传媒>First-Line Nivolumab Plus Chemo Approved for Bladder Cancer

Combination reduced risk of death by 22%

FDA APPROVED Dexcom Stelo Glucose Biosensor System over a photo of the device.

<乌鸦传媒>FDA Clears First OTC Continuous Glucose Monitor

Dexcom's Stelo system available without a prescription by the summer

FDA APPROVED Interchangeable biosimilars to Prolia and Xgeva over a computer rendering of bone affected by osteoporosis.

<乌鸦传媒>FDA OKs First Interchangeable Biosimilars for Denosumab

New products will carry all the same indications as Prolia and Xgeva, though launch date unclear

A photo of a bowl of yogurt with berries and granola

<乌鸦传媒>FDA Says Eating Yogurt May Reduce Diabetes Risk

Products will be allowed to carry claims as long as they don't mislead consumers

A photo of a man holding a can of Zyn nicotine pouches.

<乌鸦传媒>Zyn Nicotine Pouches Are All Over TikTok, Sparking Debate

Experts wrestle with their potential benefits and risks

FDA APPROVED amivantamab (Rybrevant) over a computer rendering of lung cancer.

<乌鸦传媒>FDA OKs Amivantamab as First-Line Lung Cancer Treatment

Bispecific drug lands full approval for NSCLCs with EGFR exon 20 insertion mutations

A photo of a chicken sandwich laying on its grease-proof wrapper.

<乌鸦传媒>FDA Announces End to 'Forever Chemicals' in U.S. Food Packaging

PFAS chemicals have been tied to a number of health issues

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

<乌鸦传媒>Abdominal Fat and Dementia; Mask Ban Lawsuit Tossed; FDA Rejects Psych Drug

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

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

<乌鸦传媒>Amy Schumer's Diagnosis; FDA Yanks Cancer Drug; Nursing Student Murdered

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

A photo of a Canadian flag flying from the porch of an inn in Gulfport, Florida.

<乌鸦传媒>FDA Authorized Florida's Drug Importation Plan. Naysayers Are Balking.

It's not an efficient solution

FDA APPROVED cefepime-enmetazobactam (Exblifep) over a computer rendering of a urinary tract infection

<乌鸦传媒>FDA Approves Antibiotic Combination for Complicated UTIs

Cefepime-enmetazobactam beat piperacillin-tazobactam in phase III study

FDA APPROVED Selective cytopheretic device-pediatric (SCD-PED) over a computer rendering of diseased kidneys.

<乌鸦传媒>FDA OKs Device for Pediatric Kidney Injury Due to Sepsis

The device was granted a Humanitarian Device Exemption approval

A photo of a woman watching a female physician speaking on a laptop

<乌鸦传媒>Medication Abortion Via Telehealth Safe and Effective, Study Finds

No difference in results between patients who received care via video vs secure text messaging

FDA APPROVED lifileucel (Amtagvi) over a photo of malignant melanoma on a man鈥檚 torso

<乌鸦传媒>FDA OKs First Cellular Therapy for Melanoma

Lifileucel approved as treatment for advanced melanoma after anti-PD-1 and targeted therapy

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>Treating the Tsetse's Curse

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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afib

Second catheter-based system approved for paroxysmal Afib

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