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FDA General

A bottle of (ranitidine) tablets spilled on a table.

Ranitidine Did Not Convert to Carcinogen in Two Small FDA Studies

However, don't expect the drug's return to market anytime soon, say editorialists

FDA ODAC over a PET scan of squamous carcinoma of the anal canal

Hold Off on Approving Anal Cancer Drug, Advisors Tell FDA

ODAC recommends deferring approval of new PD-1 inhibitor until confirmatory trial results are in

Cancer cells with OncoBreak in the center.

Start Thinking 'Cure'; One More Hug; Mortgages and Breast Cancer Survival

News, features, and commentary about cancer-related issues

An FDA APPROVED seal over a photo of prescription bottles on a shelf

The FDA Is Failing the American People

The agency's recent decision to approve aducanumab offers more evidence of a broken system

Vials of COVID-19 vaccine from various pharmaceutical companies.

Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines

Data should be from completed phase III trials, not interim results, group says

A waste basket view of a man throwing in a crumpled piece of paper

Op-Ed: Why Is Prescribing Information Still on Paper?

Making electronic info the default is a small change with a big environmental impact

FDA WARNING Medtronic HeartWare left ventricular assist device above a photo of the device in the palm of a mans hand

Medtronic's LVAD Pulled From Market Due to Neurological, Mortality Risks

Physicians must stop implanting the HeartWare system, says FDA

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

Guns for Vaccinations; IU Health Joins the Mandate Club; NFL Ends 'Race-Norming'

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

FDA MARKETING Cognoa ASD Diagnosis Aid (Canvas DX) over a photo of the software running on a smartphone

Novel Aid to Help Diagnose Autism Gets FDA Nod

Canvas Dx device may help early diagnoses and intervention in young children

FDA APPROVED olanzapine and samidorphan (Lybalvi)

FDA OKs New Antipsychotic for Schizophrenia, Bipolar Disorder

Approval of olanzapine-samidorphan carries opioid-related contraindications

A syringe sticking out of a vial of covid-19 vaccine with out of focus people waiting for their shot in the background

Are Vaccine Advisors More Conflicted Than We Thought?

Rules for advisory committee members' disclosures vary widely

FDA ADCOMM Teplizumab over a computer rendering of antibodies

Drug to Delay T1D Gets Tepid Endorsement by FDA Advisors

Feelings mixed on safety and efficacy evidence for novel biologic

FDA WARNING Obeticholic acid (Ocaliva) over two bottles of Ocaliva over a computer rendering of a liver with cirrhosis.

FDA Restricts Ocaliva Use in Primary Biliary Cholangitis

Liver failure, need for liver transplant reported in patients with advanced cirrhosis

5 different generic sun screen products

Bad Day Sunshine: Benzene Found in Many Sun Care Products

Valisure also detected the carcinogen in hand sanitizers earlier this year

ENDOBREAK centered between 8 illustrated body organs.

FDA Draft Guidance on T2D Devices; New GLP-1 Drug Succeeds in Trial

News and commentary from the endocrinology world

A photo of Robert Kramer, president and CEO of Emergent BioSolutions

House Dems Grill Emergent Execs Over Spoiled J&J Doses

Mixed-up ingredients, wasted taxpayer dollars, potential insider training?

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

Indian Variant a Global Risk; Good News on U.S. Cases; Baylor Expert Gets Threats

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

A still from the Regeneron TV ad which says: Tested positive for COVID-19? Call your doctor now about monoclonal antibodies.

First COVID Treatment Ads Hit the Airwaves

Regeneron hoping patients ask their doctors about monoclonal antibodies

FDA ADCOMM oral avacopan over a medical illustration of vasculitis over a photo of a persons skin with purpura from vasculiti

FDA Panel to Weigh Avacopan's Fate for ANCA Vasculitis

Agency staff called out "interpretability" of phase III trial results ahead of Thursday's meeting

A close up of a pack of Newport menthol cigarettes laying on gravel

Op-Ed: Is FDA's Cigarette Ban Just Smoke and Menthols?

Actually implementing a ban on menthol cigarettes and cigars could take years

ACOG over a conceptual illustration of obstetrics and gynecology

Thumbs Up for New Birth Control Pill Across Multiple Subgroups

No differences in efficacy or unscheduled bleeding based on age, BMI, or prior contraceptive use

Cartoon image of a man holding the back of his ear to hear better

'It's a Straw-Man Argument': What We Heard This Week

Quotable quotes from 木瓜直播's sources

FDA APPROVED dapagliflozin (Farxiga) oral tablets over a computer rendering of chronic kidney disease

Farxiga Gets FDA Greenlight for CKD

SGLT2 OK'd to prevent chronic kidney disease progression and cardiovascular risks

FDA ODAC pembrolizumab (Keytruda), nivolumab (Opdivo) over a micrograph of hepatocellular carcinoma

FDA Panel Splits on Anti-PD-1 Monotherapy in HCC

All thumbs up for pembrolizumab, pending further data, but no such luck for nivolumab

FDA APPROVED dostarlimab (Jemperli) over a computer rendering of endometrial carcinoma

PD-1 Inhibitor Approved for dMMR Endometrial Cancer

Dostarlimab led to 42.3% response rate in recurrent/advanced disease

A photo of Lisa Stockman Mauriello next to her dog and holding a sign which reads DON鈥橳 WANT TO DIE

ALS 'Compassionate Use' Again Hits National Media

Expanded access campaigns will only become more frequent with growing rare disease pipelines

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

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