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FDA General

A close up of a syringe laying in the palm of the hand of a man overdosing

Op-Ed: Addiction Is Killing Our Families

Closing treatment knowledge gaps can help

FDA APPROVED sacituzumab govitecan-hziy (Trodelvy) over a photo of the product over a microscope image of urothelial cancer

Another Player in Advanced Bladder Cancer

Accelerated FDA approval of sacituzumab govitecan after chemo, immunotherapy

COVID-19 UPDATE and Other News over a background of illustrated coronaviruses

CDC Issues Health Advisory on J&J Shot; Pfizer Ramps Up; STDs at All-Time High

A daily roundup of news on COVID-19 and the rest of medicine

A close up of a box of Mifeprex (Mifepristone) in a woman鈥檚 palms

FDA Temporarily Lifts Restriction on Abortion Pill

Allows clinicians to dispense mifepristone via telehealth during the pandemic

FDA ADCOMM TransMedics Organ Care System (OCS) Heart over a photo of the device

Donor Heart Preserver Survives Review by FDA Advisors

Panel had many bones to pick with the Transmedics OCS device

A GeneXpert Xpert Xpress SARS-CoV-2 rapid test

Common Hospital PCR Test Affected by Viral Variant

Cepheid Xpert joins three other tests for which B.1.1.7 can be problematic

A box of Lamictal (lamotrigine) tablets over an ECG with arrhythmia elements

FDA: Arrhythmia Risk With Lamotrigine May Be Class Effect

Agency updates warning for people with cardiac disease taking sodium channel blockers

FDA APPROVED Portable Neuromodulation Stimulator (PoNS) over an illustration showing how the device works

Novel Device OK'd to Treat MS Gait Deficits

Tongue stimulator generates pulses to combat ataxia

FDA APPROVED MEDTRONIC HARMONY TRANSCATHETER PULMONARY VALVE over 3 photos of the device

Harmony Pulmonary Valve Gets FDA Nod

Transcatheter valve implantation approved for people without surgical RVOT conduits

Computer rendering of an overactive bladder with the text FDA APPROVED MIRABEGRON (MYRBETRIQ)

Overactive Bladder Drug Gains Pediatric Indication

Mirabegron approved to treat kids with neurogenic detrusor overactivity

A computer rendering of monoclonal antibodies

FDA Panel Unhappy With Novel OA Pain Drug

Latest setback for troubled osteoarthritis biologic

A close up of a pile of small bottles of hand sanitizer

Benzene Found in Multiple Hand Sanitizer Brands

Known human carcinogen can be absorbed through the skin

A computer rendering of leukemia cells in the blood stream

Op-Ed: Blood Cancer Patients Need More COVID Vax Answers

Patients are left wondering, "will I be protected?"

A man holds several different nutritional supplements in his hand with many out of focus pill bottles in the background

Banned Stimulants Again Found in Supplements

Researchers question FDA's commitment to enforcement

A spotlight on a bottle of hydrocodone tablets

Op-Ed: Now Isn't the Time to Ignore the Opioid Crisis

Swift federal action can remove barriers to life-saving treatment

A photo of Joseph Mercola, DO

FDA Warns Mercola for Selling Bogus COVID Treatments

Controversial physician in trouble for claims about vitamin C, vitamin D, and quercetin products

FDA ADCOMM Ad26.COV2.S Johnson & Johnson COVID-19 vaccine over a photo of a blue rubber gloved hand holding a vial

J&J COVID Vaccine Gets Green Light from FDA Panel

No dissent on question of whether benefits outweigh risks

FDA MARKETING Q-Collar compressive device over a photo of a young man wearing a football helmet Q-Collar

Device to Prevent Athletes' Brain Injury Wins FDA Nod

Low-tech neck collar keeps brain from "sloshing" during moderate impacts

FDA ADCOMM Lutonix 014 Drug Coated Balloon PTA catheter over a computer rendering of a drug coated balloon

FDA Advisors Pan Drug-Coated Balloon for Lower-Leg Ischemia

Panel members cite muddy efficacy data

FDA APPROVED Sacubitril/valsartan (Entresto) over a photo of a man clutching his chest which is highlighted in red

First Drug Approved for Some HFpEF

FDA doesn't set hard limits on ejection fraction in expanded indication

FDA APPROVED trilaciclib (Cosela) over a microscope image of bone marrow above

New Drug OK'd for Chemo-Induced Myelosuppression in SCLC

CDK4/6 inhibitor cut the risk for severe neutropenia in small-cell lung cancer patients

cemiplimab (LIBTAYO) over a photo of basal cell carcinoma above FDA APPROVED

First Immunotherapy Approved for Basal Cell Carcinoma

Objective responses in 27% of previously treated patients who received cemiplimab

pembrolizumab (Keytruda) over a close up of a pink breast cancer ribbon pinned to a woman鈥檚 tank top above FDA ODAC

FDA Panel Slows the Roll for Pembrolizumab in Breast Cancer

Advisory committee: Wait for more data before considering neoadjuvant indication

pembrolizumab (Keytruda) over a close up of a pink breast cancer ribbon pinned to a woman鈥檚 tank top above FDA ODAC

Has Pembrolizumab Finally Met an Indication FDA Doesn't Like?

Agency staff skeptical of data in early breast cancer

A photo of Missouri State representative Patricia 鈥淭ricia鈥� Ashton Derges

HCP Busted for Selling Fake Stem Cell Therapy

Assistant physician and Missouri state legislator indicted for wire fraud, other crimes

STS over a computer rendering of a transparent body with the heart and lungs highlighted

Combined Cath Approach No Match for Surgery for Aortic Stenosis, CAD

Pacemakers increasingly an issue in TAVR plus PCI

STS over a computer rendering of a transparent body with the heart and lungs highlighted

Will Recovering COVID-19 Patients Soon Be Walking Around on ECMO?

This year's winner of the STS "Shark Tank" session

A box of Xeljanz (tofacitinib) tablets over a background of thumbs down icons

JAK Inhibitor Misses Endpoint in Safety Study. Now What?

Major blow to popular class of oral rheumatology drugs

Cancer cells with OncoBreak in the center.

Cancer and COVID; Booze and Cancer; 'Screech' Starts Chemo

News, features, and commentary about cancer-related issues

Feds Crack Down on Vitamin D COVID 'Cures'

Georgia-based companies ordered to stop sales after national recall, DOJ says

A paper speech bubble with ALLERGY punched out of it laying on a pile of peanuts in shells.

Promising Peanut Allergy Treatments Hit Snags in 2020

COVID-19 interrupts Palforzia rollout; FDA slams door on competitor's patch therapy

A RECALL ALERT stamp over a bottle of Metformin Extended Release tablets

Metformin Recalls Ballooned in 2020

Last addition to the list in November brought number to 254 products recalled

How Do We Inject Confidence Into Vaccine Hesitant Americans?

"We need to really up our game in terms of communicating," says Peter Hotez, MD, PhD

Left ventricular assist device (HeartMate 3) over a computer rendering of the device attached to a heart above FDA APPROVED

LVAD Approved for Children

FDA clears the way for HeartMate 3 use in younger population

COVID-19 UPDATE and Other News over a background of illustrated coronaviruses

'We Want Them Infected'; Extra Vax Doses; Tom Cruise, Distancing Enforcer

A daily roundup of news on COVID-19 and the rest of medicine

sacubitril/valsartan (ENTRESTO) over a computer rendering of a heart above FDA ADCOMM

FDA Panel Backs Entresto, Spironolactone for Broader HF Use

But committee stops short of advocating categorical approval for HFpEF

Bridge-EnhancedACL Repair (BEAR) Implant over a computer rendering of the implant above FDA APPROVED

FDA OK's First-Ever Synthetic Implant for ACL Tears

Bioresorbable device fills gap between torn ligament ends

Sacubitril/Valsartan (Entresto) over a computer rendering of the cardiovascular system above FDA ADCOMM.

FDA Review Gives Rosy Outlook for What Could Be First HFpEF Drugs

Advisory committee weigh unusual moves for Entresto and spironolactone

Liraglutide (Saxenda) over a photo of an overweight teen male above FDA APPROVED

Saxenda OK'd for Teens with Obesity

Liraglutide label now includes adolescents as young as 12

Gallium 68PSMA-11 (Ga 68 PSMA-11) over a computer rendering of prostate cancer above FDA APPROVED

FDA OKs 'Game Changer' Radiotracer for Prostate Cancer

PET imaging drug detected metastasis at initial diagnosis, outperformed standard for PSA recurrence

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