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FDA General

Lawrence O. Gostin, JD, LLD, and Sarah Wetter, JD, MPH

Here Are the Top Supreme Court Health Cases to Watch

A slew of cases this term could reshape health policy

NYV over a photo of Jacob K. Javits Convention Center in New York City, NY

New Tricuspid Interventions Launched into 'Broken' System

Having the technology reach the right patients is a major challenge in the real world

FDA APPROVED imetelstat (Rytelo) over a photo of a bag of blood in blue rubber gloved hands.

Telomerase Inhibitor Approved for MDS-Related Anemia

Imetelstat indicated for lower-risk myelodysplastic syndromes with transfusion-dependent anemia

FDA ADCOMM donanemab over a computer rendering of neurons affected by Alzheimer鈥檚 disease.

FDA Reviewers Question Patient Selection for Alzheimer's Drug Candidate

Agency's advisors will discuss efficacy, safety of investigational donanemab

NYV over a photo of Jacob K. Javits Convention Center in New York City, NY

Can Mitral Valve Innovators Dig Themselves Out of a Rut?

Current transcatheter mitral valve replacement devices a poor match for clinical need

FDA MARKETING JUUL over a photo of the product.

Juul Vaping Products' Stay of Execution Is Now More Official

FDA rescinds marketing denials pending further review

FDA ADCOMM 2024-2025 formula for COVID-19 vaccines over a photo of a syringe drawing from a vial.

FDA Advisors Give a Hearty Thumbs Up to a COVID Vaccine Based on the JN.1 Strain

"Even with some variation, there's still reasonably good protection"

A graphic from Safari Regenerative Therapy which reads: Get Over It! Stem Cells Work!

FDA Warns Company Making Stem Cell Products for Pets

Safari Stem Cell claims its products can treat a range of animal diseases, FDA says

FDA ADCOMM midomafetamine capsules (MDMA, Lykos Therapeutics) over a close up photo of drug capsules

FDA Panel Votes Against MDMA for PTSD

Advisors raised concerns about efficacy, safety, trial design, misconduct

FDA ADCOMM 2024-2025 formula for COVID-19 vaccines over a photo of a syringe drawing from a vial.

FDA Panel to Consider Which COVID Strain to Target in an Updated Vaccine

The KP.2 subvariant is now dominant in the U.S., FDA staff says in a briefing document

A photo of two male farmers talking in a dairy cow barn.

'Uncertainty' Isn't a Bad Word: U.S. Agencies Must Tighten Up H5N1 Communications

More effective and efficient public messaging is the need of the hour

FDA ADCOMM midomafetamine capsules (MDMA, Lykos Therapeutics) over a close up photo of drug capsules

FDA Staff Questions Safety of MDMA Treatment for PTSD

Advisory committee will weigh benefits and risks next week

FDA APPROVED mRNA-1345 vaccine (mRESVIA) over a computer rendering of respiratory syncytial viruses.

FDA Approves First mRNA RSV Vaccine

Moderna vaccine indicated for people ages 60 and up

A photo of a female lab technician using a pipette to transfer material.

Company Warned Over Atypical Fat-Derived Stem Cell Product

Stromal vascular fraction isn't usually sourced from donors

A photo of donor cornea for transplant.

FDA Urged to Relax Tissue Donation Restrictions for Gay, Bisexual Men

Advocates say policy should be based on individualized risk assessments, "not historic bias"

FDA ADCOMM insulin icodec (Awiqli) over a photo of a man holding an injection pen to his stomach.

FDA Advisors Not Convinced Once-Weekly Insulin Is Safe in Type 1 Diabetes

Risk of severe hypoglycemia was too much for panel members to overcome

FDA ADCOMM Blood-based colorectal cancer test (Shield) over a photo of the product.

Blood Test for Colon Cancer Screening Secures FDA Panel's Blessing

But advisors urge strong labeling emphasizing Shield test's low sensitivity for advanced adenomas

A screenshot of Jeffrey Shuren, MD, JD, director of the FDA鈥檚 Center for Devices and Radiological Health speaking during this

House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines

Agency official also seeks Congress's help with preventing device shortages

FDA ADCOMM insulin icodec (Awiqli) over a photo of a man holding an injection pen to his stomach.

Will FDA Advisors Look Past Hypoglycemia Risk With Once-Weekly Insulin?

Hypoglycemia was only a concern in patients with type 1 diabetes

FDA ADCOMM Blood-based colorectal cancer test (Shield) over a photo of the product.

Blood Test for Colon Cancer Screening May Miss Some Precancers, FDA Staff Says

Shield could boost screening compliance, but has low sensitivity for advanced adenomas

FDA WITHDRAWN infigratinib (Truseltiq) over a photo of a box of Truseltiq capsules.

FDA Withdraws Approval of FGFR Inhibitor for Bile Duct Cancer

Sponsor for infigratinib (Truseltiq) failed to recruit and enroll patients in confirmatory study

FDA APPROVED aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz) over a photo of age-related macular degeneration

FDA Approves First Interchangeable Biosimilars to Aflibercept for AMD

Yesafili and Opuviz can be substituted at a pharmacy without consulting the prescriber

FDA APPROVED tarlatamab (Imdelltra) over a computer rendering of small cell lung cancer

FDA OKs Novel BiTE Agent for Small Cell Lung Cancer

First-in-class tarlatamab achieved a 40% ORR in previously treated extensive-stage SCLC

FDA APPROVED Human papillomavirus self-collection test over a photo of a woman holding a swab and sample container.

FDA Approves New Self-Collection Option for HPV Testing

Provides women a way to privately collect their own samples, says maker Roche

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Dark Side of MDMA's Journey to FDA; Fake Studies Shutter Journals; H5N1 Turf Wars

This past week in healthcare investigations

A photo of the U.S. Patent and Trademark Office in Alexandria, Virginia.

Blockbuster Drug Patent Thickets Signal 'Strategic Behavior'

Nearly three-quarters filed after approval, and most claims "peripheral" to active ingredients

A photo of a marijuana leaf lying on an American flag.

Lost in the Haze: What Would Rescheduling Marijuana Really Do?

If you are confused, you're not alone

A close up photo of a woman鈥檚 hand with an IV line attached.

Ending Oncology's Toxic Relationship With High Chemotherapy Doses

Optimizing doses can improve patient outcomes and lower costs

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

Diet Tied to Mortality; FDA's Financial Ties; New Long COVID Trials to Start

Health news and commentary gathered by 木瓜直播 staff

FDA RECALL t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology over the device.

FDA Warns on Insulin Pump Problem

Mobile app glitch may cause t:slim X2 insulin pump battery to drain sooner than expected

A screenshot of Robert Califf, MD, speaking during this hearing.

FDA Chief on H5N1: 'We Have to Be Ready'

Commissioner also detailed plans for "largest reorganization" in agency's history

SCAI over a photo of Long Beach Convention Center in Long Beach, CA

What Is Going on With Catheter-Based Pulmonary Embolism Devices in the Real World?

Researchers try to make do with the scant data on advanced PE intervention

A photo of a pregnant woman holding a blisterpack of tablets.

Rare Pregnancy Problem Linked to Thiopurines, FDA Says

Agency finds risk for intrahepatic cholestasis of pregnancy mostly in IBD, lupus patients

A photo of a Narcan nasal spray applicator.

Narcan May Have Moved Over-the-Counter, but It鈥檚 Still Underutilized

The potential of this lifesaving medicine will only be achieved if it is truly accessible to all

A photo of an semaglutide (Ozempic) injector pen.

FTC Challenges 'Bogus' Patents on Ozempic and Other Drugs

Patents block competition and inflate prescription drug cost, says FTC chair

A photo of a white pill on the tip of a man鈥檚 finger.

Why Don't Men Have Their Version of 'The Pill'?

A focus on gender equity should include contraceptive equity too

A photo of a female lab technician using a pipette in a laboratory.

FDA Brings Lab Tests Under Its Oversight

Agency will treat lab-developed tests the same as other in vitro diagnostics

FDA APPROVED Esprit BTK everolimus-eluting scaffold system over a computer rendering of the device.

Dissolving Stent Approved for Peripheral Artery Disease Below the Knee

The Esprit BTK everolimus-eluting scaffold is indicated for chronic limb-threatening ischemia

A photo of the Philips Center, in Amsterdam, Netherlands

Philips to Pay Over $1 Billion to Resolve Lawsuits Over Sleep Apnea Devices

Payout includes medical monitoring claims from patients who used company's CPAP, BiPAP machines

FDA APPROVED mavorixafor (Xolremdi) over a photo of warts on a woman鈥檚 hand.

FDA Approves First Drug for WHIM Syndrome

CXCR4 antagonist mavorixafor effectively boosts neutrophils and lymphocytes to reduce infections

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