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The Latest Breaking News from FDA

Departures roil the CDC leadership. What's next for the agency?

Operations at the U.S. Centers for Disease Control and Prevention are in jeopardy after the ousting of the CDC director and the resignation of several high-profile agency leaders

The Independent UK

Prothena Reports Non-Competitive Brain Swelling Rates In Early Alzheimer's Study

Prothena Corporation plc (NASDAQ:PRTA) shared results on Wednesday from the Phase 1 ASCENT clinical program in participants with early symptomatic Alzheimer’s disease (AD).

Benzinga

Telix Gets Second FDA Rejection For Kidney Cancer Drug

On Thursday, Telix Pharmaceuticals Limited (NASDAQ:TLX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

Benzinga

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People in the US: share your views on the FDA’s new restrictions on Covid jabs for under-65s

We want to hear people’s views about the change making only those 65 and up automatically eligible for the vaccines

The Guardian - US

FDA Eases Monitoring Burden For Kidney Disease Patients On Travere Therapeutics' Filspari

The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.’s (NASDAQ:TVTX) Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for IgA nephropathy (IgAN).

Benzinga

RFK Jr faces calls to quit as CDC chief fired and senior staff resign: ‘an embarrassment’

Susan Monarez’s ousting and four top resignations follow vaccine confusion, leaving US health agencies in turmoil

The Guardian - US

FDA Rejects Outlook Therapeutics Eye Drug For Second Time

Outlook Therapeutics, Inc. (NASDAQ:OTLK) stock plunged on Thursday after the U.S. Food and Drug Administration (FDA) update.

Benzinga

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The Latest: White House says CDC director is fired, agency leaders resign

The director of the nation’s top public health agency is challenging a White House announcement that she's been fired, and several other top leaders of the U.S. Centers for Disease Control and Prevention have resigned, saying President Donald Trump’s administration is putting politics in the way of keeping Americans safe

The Independent UK

Pregnant women face tough choices about medication use due to lack of safety data − here’s why medical research cuts will make it worse

A panel convened in July 2025 by the Food and Drug Administration sparked controversy by casting doubt about the safety of commonly used antidepressants during pregnancy. But it also raised the broader issue of how little is known about the safety of many medications used in pregnancy, considering the implications…

The Conversation

How Elon Musk’s billionaire Doge lieutenant took over the US’s biggest MDMA company

Antonio Gracias is part of the growing movement among Silicon Valley’s right wing enamored with the therapeutic and commercial potential of drugs like MDMA

The Guardian - US

CDC Director Susan Monarez Defies Ouster, Vows To Protect Science Amid Robert Kennedy Jr. Vaccine Policy Clash

Susan Monarez, confirmed as Centers for Disease Control and Prevention director in July 2025, refused to resign on Wednesday after reports of her removal sparked a major public health controversy.

Benzinga

FDA approves updated COVID-19 vaccines with new restrictions, potentially limiting access for healthy children

Guidance around COVID-19 vaccines has once again shifted after the Food and Drug Administration on Aug. 27, 2025, approved updated shots for the fall season, but for a more limited group than in prior seasons.

The Conversation

RFK Jr. Rescinds Emergency Authorizations For COVID-19 Vaccines

Health and Human Services Secretary Robert F. Kennedy Jr. announced on social media that the emergency use authorizations for COVID-19 vaccines have now been rescinded.

Benzinga

Getting a COVID-19 vaccine is getting more and more difficult. Here’s why

It depends on your age, insurance coverage, health and finding a health care professional who will give you the shot

The Independent UK

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The Guardian - US

FDA approves new Covid-19 vaccines in US but limits who can get them

Agency authorizes shots for those 65 and older, with young people eligible if they have underlying medical conditions

The Independent UK

FDA approves updated COVID-19 shots but limits access for some kids and adults

The Food and Drug Administration has approved updated COVID-19 vaccines for the upcoming fall and winter season

Roll Call

FDA sets more limited framework for COVID-19 vaccines - Roll Call

The FDA approved COVID-19 vaccines under a more limited framework after rescinding the emergency use authorizations previously in place.

The Independent UK

Salmonella and listeria concerns spark pet food recall

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Benzinga

BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

BioXcel Therapeutics Inc. (NASDAQ:BTAI) announced that its SERENITY At-Home Phase 3 trial of BXCL501—its sublingual dexmedetomidine film for acute agitation in bipolar disorder or schizophrenia—met its primary endpoint.

The Independent UK

Dog and cat food recalled over salmonella and listeria concerns as warning issued to owners

The recalled pet food was sold in seven states

The Texas Tribune

Texas Legislature approves bill making ivermectin an over-the-counter drug

Some people use the drug to treat COVID, even though it’s not approved by the FDA for such use. The bill now awaits the governor’s signature.

Benzinga

BioXcel Stock Surges 19% In After-Hours Trading: What You Need To Know

BioXcel Therapeutics Inc. (NASDAQ:BTAI) experienced significant after-hours momentum, jumping 19.09% to $6.24 in the after-hours trading session on Tuesday, as investors got ready for the release of important clinical trial results.

The Independent UK

A new strain of Covid is causing a spike in California as officials grapple with Trump’s vaccine policies

Health officials under Robert F. Kennedy Jr. have delayed and gummed up the approval of new Covid-19 jabs even as the new ‘Stratus’ subvariant surges in the Golden State

Benzinga

Gyre Therapeutics Gains Attention As Under-The-Radar Liver Fibrosis Drug Maker

The global biopharmaceutical landscape is rapidly evolving, driven by innovations targeting complex diseases like organ fibrosis and liver conditions. As companies push the boundaries of medical science, new therapies are emerging that promise to transform patient care and redefine market leadership in these critical areas.

Benzinga

Argenx Immune Disorder Drug's Reach Could Get Much Bigger With Major Trial Win

Argenx SE (NASDAQ:ARGX) stock is trading higher on continued upward momentum after the company released topline data on Monday from the pivotal Phase 3 ADAPT SERON study of Vyvgart (IV: efgartigimod alfa-fcab).

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