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FDA General

FDA ODAC imetelstat (Rytelo) over a close up photo of a person receiving a blood transfusion.

FDA Staff Cast Doubt on Novel Drug for MDS-Related Anemia

Agency asking its advisors if benefits outweigh risks for patients who fail on standard treatment

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

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.

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.

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.

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

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.

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.

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.

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.

Abdominal Fat and Dementia; Mask Ban Lawsuit Tossed; FDA Rejects Psych Drug

Health news and commentary from around the Web gathered by 麻豆传媒 staff

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

Amy Schumer's Diagnosis; FDA Yanks Cancer Drug; Nursing Student Murdered

Health news and commentary from around the Web gathered by 麻豆传媒 staff

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

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

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.

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

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

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

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

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