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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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FDA WITHDRAWN infigratinib (Truseltiq) over a photo of a box of Truseltiq capsules.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Diet Tied to Mortality; FDA's Financial Ties; New Long COVID Trials to Start

Health news and commentary gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>FDA Approves First Drug for WHIM Syndrome

CXCR4 antagonist mavorixafor effectively boosts neutrophils and lymphocytes to reduce infections

Illustration of red blood cells.

<乌鸦传媒>FDA OKs Second Gene Therapy for Hemophilia B

One dose of fidanacogene elaparvovec proved noninferior to standard prophylactic factor IX

The words Urinary Tract Infection on a piece of paper covered with pills.

<乌鸦传媒>FDA Approves New Option for Uncomplicated UTIs in Women

Antibiotic widely used in other countries now available in the U.S.

Cows are seen at a dairy in California

<乌鸦传媒>Remnants of Bird Flu Virus Found in Pasteurized Milk, FDA Says

Agency stressed that the material is inactivated

FDA APPROVED tovorafenib (Ojemda) over a CT scan of a glioma.

<乌鸦传媒>New Targeted Drug Approved for Low-Grade Glioma in Kids

First systemic therapy for pediatric patients with BRAF rearrangements

FDA APPROVED nogapendekin alfa inbakicept-pmln (Anktiva) over a computer rendering of bladder cancer.

<乌鸦传媒>FDA OKs First IL-15 Receptor Agonist for Early Bladder Cancer

Novel immunotherapy induced complete responses in 62% of patients with BCG-unresponsive NMIBC

A computer rendering of tweezers attaching a microchip to a brain.

<乌鸦传媒>Neurotechnology Development Must Be Slow and Steady

The burgeoning field holds both promise and risks

FDA RECALL HeartMate II and HeartMate 3 over a photo of the HeartMate 3 device on an anatomical heart model.

<乌鸦传媒>FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries

Recall comes years after issues were first raised

FDA APPROVED alectinib (Alecensa) over a computer rendering of lung cancer.

<乌鸦传媒>Alectinib Lands FDA Approval for Adjuvant Therapy in NSCLC

The ALK inhibitor reduced the risk of recurrence or death by 76% versus chemotherapy

FDA APPROVED pegulicianine (LumiSight) over a photo of the product.

<乌鸦传媒>FDA Greenlights Imaging Agent to Detect Residual Cancer After Lumpectomy

Pegulicianine used with an approved imaging system achieved overall diagnostic accuracy of 84%

FDA RECALL Obsidio Conformable Embolic over a computer rendering of the product.

<乌鸦传媒>FDA Slaps Embolization Device With Class I Recall After Deaths

Increased bowel ischemia risk when Obsidio Embolic is used for lower GI bleeds

AAN over a photo of Colorado Convention Center in Denver, CO

<乌鸦传媒>Why an ALS Drug Was Pulled From the Market

Topline data show where sodium phenylbutyrate and taurursodiol fell short

A photo of Holstein dairy cows in an outdoor feeding pen in Texas

<乌鸦传媒>The H5N1 Outbreak Is Not a Test Run, It's a Warning Shot

A true public health success would be preventing the virus from further adapting to humans

A photo of a line of Holstein dairy cows feeding through a fence at a dairy farm in Idaho

<乌鸦传媒>Bird Flu Is Spreading to More Farm Animals. Are Milk and Eggs Safe?

Health officials say the risk to the public is low and the food supply remains safe

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

<乌鸦传媒>FDA Chief Blasted for Infant Formula Crisis Response, COVID Vaccines

Republican lawmakers questioned why the agency is "failing to do the bare minimum"

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

<乌鸦传媒>Doc Fired After Deaths; Mass Shooting Blamed on Abortion Law; Record Drug Shortages

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

FDA APPROVED benralizumab (Fasenra) over a computer rendering of an inflamed bronchial tube.

<乌鸦传媒>FDA Expands Approval of Severe Asthma Drug

Add-on maintenance therapy benralizumab now indicated for children ages 6 to 11 years as well

A photo of Jeffrey Reed at home next to his Philips continuous positive airway pressure (CPAP) machine.

<乌鸦传媒>After Massive CPAP Recall, Philips Ordered to Overhaul Manufacturing

More than 5 million machines have been recalled since 2021

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