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

RFK Jr. Spurs FDA Resignations; Chatbot to User: 'Please Die'; Dating Apps and STIs

Health news and commentary gathered by 木瓜直播 staff

FDA APPROVED eladocagene exuparvovec-tneq (Kebilidi) over a computer rendering of nerve cells.

First Brain-Delivered Gene Therapy Approved for AADC Deficiency

Novel treatment is indicated for children and adults with the rare disorder

This combination of images from video shows scenes from Nasonex television commercials broadcast in the U.S. in the 2000s.

New FDA Rules for TV Drug Ads: Simpler Language and No Distractions

Agency spent over 15 years crafting the guidelines

A photo of bottles of Ocaliva tablets over a computer rendering of the gallbladder with bile duct and biliary tree.

FDA Rejects Full Approval of Liver Disease Drug

Agency's decision on obeticholic acid in PBC follows negative advisory committee meeting

A photo of mifepristone tablets in a Planned Parenthood clinic July 18, 2024, in Ames, Iowa.

Anti-Abortion Groups Press Trump for More Restrictions as Abortion Pill Sales Spike

Advocates look to undo Biden administration's policies

FDA APPROVED obecabtagene autoleucel (Aucatzyl) over a rendering of CAR-T cells attacking lymphoblastic leukemia cells.

New CAR T-Cell Therapy Approved for Leukemia

Obecabtagene autoleucel has no requirement for a REMS program

A close up photo of a needle of a semaglutide injection pen.

FDA Adds New Warning to GLP-1 Drugs

Labels now caution about pulmonary aspiration risk

FDA ADCOMM ProSense cryoablation system over a computer rendering of the device freezing a breast tumor.

FDA Panel Backs Cryoablation in Early Breast Cancer as Alternative to Surgery

ProSense device would be indicated with adjuvant endocrine therapy for some low-risk patients

A photo of cold and allergy medication on the shelf at a Walgreens.

FDA Plans to Ban Popular Cold Med

Data review shows that oral phenylephrine is not effective as a decongestant, agency says

A photo of an empty White House press briefing room.

Election Redux: Public Health Just Got a Lot More Difficult

We must continue to fight

FDA MARKETING Light delivery system (Valeda) over photos of the product.

FDA Grants Market Authorization to Light-Therapy System for Dry AMD

Valeda photobiomodulation system slowed disease progression and improved vision

A photo of Donald Trump.

What Trump Has Proposed for Healthcare in a Second Administration

A look at Trump's history and ideas floated on the campaign trail

FDA APPROVED minocycline hydrochloride extended-release capsules (Emrosi) over a photo of a woman with rosacea on her cheeks

FDA Approves New Option for Rosacea

Antibiotic Emrosi topped doxycycline, placebo in phase III trials

A photo of Donald Trump shaking hands with Robert F. Kennedy Jr. during a rally in Duluth, Georgia.

RFK Jr. Threatens the Very Fabric of Healthcare

A vote to give Kennedy power is a vote against public health

How the Election Results Could Affect Healthcare in the U.S.

Anand Parekh breaks down the possible futures for abortion rights, EMTALA, and Obamacare

A photo of Donald Trump in the Oval Office.

What Will CDC, FDA, and CMS Look Like After the Election?

We talked to healthcare experts to get their predictions for a Trump or Harris administration

FDA ADCOMM sotagliflozin over a computer rendering of chronic kidney disease.

FDA Panel Rejects SGLT1/2 Inhibitor for Type 1 Diabetes

Data too uncertain to support sotagliflozin in subset with chronic kidney disease, advisors say

A photo of Robert F. Kennedy Jr., speaking at a Trump campaign rally at Madison Square Garden in New York.

RFK Jr. Wants Access to Federal Data to Show Vaccines Are Unsafe, Trump Advisor Says

Goal is to get vaccines pulled from the market, according to Trump transition leader

A computer rendering of antibodies attacking a COVID virus.

Old Drugs, New Tricks: The Power of Medication Repurposing

COVID highlighted the untapped potential of existing treatments

The advertisement for this Instagram Live event.

IG Live November 1: Healthcare Is on the Ballot

Public health and access to care are at stake in the 2024 election

A photo of Robert Francis Kennedy Jr.

Could RFK Jr. Really Become HHS Secretary?

It seems unlikely, but Washington insiders say they've come to expect the unexpected

A photo of pair of Apple AirPods Pro 2 are displayed on a table at Brooklyn College鈥檚 audiology clinic in New York.

AirPods' Hearing Aid Feature Could Help People Face a Problem They'd Rather Ignore

Apple's new feature can boost voices, media, and phone calls, and maybe lessen stigma

A photo of the Supreme Court building in Washington, DC.

A Look at the Supreme Court's Upcoming Term

Public health is on the chopping block once again

FDA APPROVED sulopenem etzadroxil and probenecid (Orlynvah) over a computer rendering of a urinary tract infection.

FDA Approves Novel Treatment for UTIs

New oral antibiotic gets a nod for uncomplicated urinary tract infections

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

Ob/Gyn Attack Caught on Tape; Antidepressant Recall; Onions Eyed as E. Coli Source

Health news and commentary gathered by 木瓜直播 staff

A photo of a vial of amniotic fluid in a laboratory.

FDA Warns Companies Over Products Made With Amniotic Fluid

Agency says PalinGen products are unapproved drugs

AAO over a photo of McCormick Place in Chicago, IL.

Approval of Bevacizumab Biosimilar for Ophthalmic Use Could Upend Low-Cost Anti-VEGF

Provision in drug act would prohibit repackaging Avastin, add millions to anti-VEGF therapy cost

FDA APPROVED Bivalent RSV prefusion F (RSVpreF) vaccine (Abrysvo) over a computer rendering of respiratory syncytial virus (R

FDA Expands Approval of RSV Vaccine Abrysvo to Include All At-Risk Adults

Decision was based on need for RSV protection in younger people with chronic conditions

A photo of a bag of IV fluids hanging from a pole as seen from a patient鈥檚 perspective.

What Will the IV Fluid Shortage Mean for Hospital Finance?

A more strategic approach to production is key to preventing crises like this

FDA APPROVED FDA has approved zolbetuximab (Vyloy) over a computer rendering of a monoclonal antibody and cancer cells.

Novel Targeted Drug Approved for Stomach Cancers

Zolbetuximab indicated alongside fluoropyrimidine- and platinum-containing chemotherapy

A photo of the packaging and vial of Trodelvy.

Drugmaker Pulls Trodelvy's Bladder Cancer Approval

In confirmatory trial, antibody-drug conjugate failed to improve OS versus chemotherapy

A photo of a man holding a Medtronic MiniMed 780G pump.

Serious Battery Issue Prompts Medtronic Insulin Pump Recall

Problem linked to 170 reports of hyperglycemia and 11 ketoacidosis cases

FDA APPROVED foscarbidopa and foslevodopa (Vyalev) over a computer rendering of Lewy bodies.

Continuous Parkinson's Disease Therapy Wins FDA Nod

Round-the-clock infusion delivers carbidopa and levodopa pro-drugs

A photo of a mifepristone tablet in a patient鈥檚 hand during a visit to a clinic in Kansas City, KS.

Three States Renew Effort to Reduce Access to Abortion Pill Mifepristone

Lawsuit aims to require three in-person doctor visits, bar drug's use after 7 weeks of pregnancy

The Supreme Court's Open Season on Public Health Agencies

"I just had this reverence for the court. I don't anymore," says Lawrence Gostin, JD

A photo of a spoon full of poppy seeds and poppy capsules in the background.

Poppy Seed Brew Triggers Morphine Overdose, Drawing Attention of Lawmakers

During harvesting and processing, the seeds can become coated with the opium

FDA APPROVED marstacimab-hncq (Hympavzi) over a computer rendering of a leaking blood vessel.

Marstacimab Gets FDA Nod for Hemophilia A or B Without Inhibitors

First once-weekly subcutaneous prophylactic option for hemophilia B

FDA ADCOMM elamipretide hydrochloride injection over a computer rendering of mitochondria.

Elamipretide for Barth Syndrome Survives FDA Advisory Vote

Panelists acknowledge difficulty generating stronger data in ultra-rare disease

inavolisib (Itovebi) over a computer rendering of advanced breast cancer.

PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer

Adding inavolisib to palbociclib/fulvestrant more than doubled PFS in endocrine-resistant disease

A closeup photo of a pulse oximeter on a man鈥檚 finger.

FDA's Promised Guidance on Pulse Oximeters Unlikely to End Decades of Racial Bias

Devices three times as likely to miss dangerously low blood oxygen in Black patients

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