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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Old Drugs, New Tricks: The Power of Medication Repurposing

COVID highlighted the untapped potential of existing treatments

The advertisement for this Instagram Live event.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Ob/Gyn Attack Caught on Tape; Antidepressant Recall; Onions Eyed as E. Coli Source

Health news and commentary gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Novel Targeted Drug Approved for Stomach Cancers

Zolbetuximab indicated alongside fluoropyrimidine- and platinum-containing chemotherapy

A photo of the packaging and vial of Trodelvy.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

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

<乌鸦传媒>FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome

Agency appears unswayed by mitochondria-targeting drug for rare cardioskeletal disease

<乌鸦传媒>How Did Public Health Become a Public Enemy at the Supreme Court?

Conservative majority is "buying into" anti-science attitudes, warns Lawrence Gostin, JD

A photo of a man holding a Saxenda injection pen.

<乌鸦传媒>Should I Prescribe Liraglutide to a 6-Year-Old Patient With Obesity if FDA Approved?

I anticipate benefits outweighing potential risks in only a select few situations

A photo of a healthcare worker injecting stem cells into a man鈥檚 knee.

<乌鸦传媒>Judge Rules Against Stem Cell Clinic

Two federal court decisions now hold that fat-derived stem cell treatment is a drug

A photo of Jen Brull, MD.

<乌鸦传媒>Elevating Family Medicine Is Key for New AAFP President

Jen Brull, MD, outlines her priorities for the coming year

FDA ODAC PD-(L)1 inhibitors over a computer rendering of esophageal cancer

<乌鸦传媒>No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel Says

Despite problematic dataset, risk/benefit profile not favorable with PD-L1 expression below 1

FDA APPROVED dupilumab (Dupixent) over a computer rendering of a transparent body with the lung bronchi highlighted.

<乌鸦传媒>First-Ever Biologic Approved for COPD

Phase III trial program showed 30% to 34% reduction in moderate or severe exacerbations

FDA APPROVED anomeline and trospium chloride (Cobenfy) over a computer rendering of a brain.

<乌鸦传媒>FDA Approves First Novel Drug for Schizophrenia in Decades

Xanomeline and trospium chloride (Cobenfy) has no boxed warnings

A photo of a bottle of Oxbrita tablets.

<乌鸦传媒>Sickle Cell Disease Drug Pulled From Global Markets

Benefits of voxelotor (Oxbryta) no longer outweigh the risks, Pfizer says

FDA APPROVED osimertinib (Tagrisso) over a computer rendering of lung cancer.

<乌鸦传媒>FDA Expands Approval of Osimertinib in Lung Cancer

EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy

FDA APPROVED levacetylleucine (Aqneursa) over a computer rendering of mutating DNA.

<乌鸦传媒>Second Drug OK'd for Ultra-Rare Neurodegenerative Disease

FDA approves levacetylleucine (Aqneursa) for Niemann-Pick disease type C

The advertisement for this Instagram Live event.

<乌鸦传媒>IG Live September 27: Court Adjourned, Healthcare Overturned

Decoding recent SCOTUS decisions and their potential impact on healthcare

FDA ODAC PD-(L)1 inhibitors over a computer rendering of esophageal cancer

<乌鸦传媒>Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says

Data since approvals suggest benefits limited to subgroups with PD-L1 expression of at least 1%

FDA APPROVED Nasal spray influenza vaccine (FluMist) over a photo of the product.

<乌鸦传媒>FDA OKs First Flu Vaccine for At-Home Use

FluMist nasal spray can now be used without the help of a healthcare provider

FDA APPROVED arimoclomol (Miplyffa) over a computer rendering of a strand of DNA.

<乌鸦传媒>First Drug Approved for Niemann-Pick Disease Type C

Arimoclomol (Miplyffa) greenlit for ultra-rare genetic disorder

FDA CRL tradipitant (Vanda) over a computer rendering of a stomach.

<乌鸦传媒>FDA Rejects NK1R Antagonist for Gastroparesis

Drugmaker none-too-pleased with agency's request for additional studies

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