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STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
STAT · 1d agoApprovalPositive↗ source
Six key issues we’re watching at Fauci’s hearing
Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
STAT · 1d agoRegulatoryNeutral↗ source

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Infectious Disease4

FDA reminds investors about the risks of advisory panels

Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and

Endpoints · 1d agoRegulatoryNeutral↗ source

FDA offers updated guidance for generics of weight loss blockbusters

The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…

Endpoints · 1d agoRegulatoryNeutral↗ source

STAT+: Bracing for another Fauci hearing

Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.

STAT · 1d agoRegulatoryNeutral↗ source

FDA staff say Replimune's melanoma trial failed to prove RP1 works

FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…

Endpoints · 1d agoRegulatoryNeutral↗ source

The future of gray-market peptides

Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...

Endpoints · 1d agoRegulatoryNeutral↗ source

STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials

New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment

Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more

The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Three questions with Whoop’s new CMO

In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.

STAT · 1d agoRegulatoryNeutral↗ source

Anthony Fauci’s pandemic-era diary entries

New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds

STAT · 1d agoRegulatoryNeutral↗ source

After PCOS became PMOS, there’s hope for new awareness among Black and Latina women

Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.

STAT · 1d agoRegulatoryNeutral↗ source

Opinion: STAT+: Dementia finally has a business model

The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD

Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories

One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.

STAT · 1d agoRegulatoryNeutral↗ source

ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions

The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…

STAT · 1d agoNegative↗ source

J&J proposes $5.5B talc settlement

After more than a decade and three failed bankruptcy attempts, an end to Johnson & Johnson’s talc saga may finally be in sight. The company has proposed a $5.5 billion settlement ...

Endpoints · 1d agoNeutral↗ source

Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3

💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...

Endpoints · 1d agoNeutral↗ source

Alnylam's stock is down 30% despite a booming biotech market. Here's why

Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A is up, IPOs are back with record-breaking force a…

Endpoints · 1d agoNeutral↗ source

Mirae raises $5.4M to turn patient texts into data for doctors

As people increasingly turn to AI chatbots for health questions, one startup wants patients to talk to its chatbot about their symptoms, so their doctors can make better treatment decisions. Mirae,…

Endpoints · 1d agoNeutral↗ source

Claris collects $118M to take eye drop into pivotal testing next year

Claris Bio has a fresh CEO, new board chair and $118 million for two pivotal trials to see if its eye drop can succeed in a blinding disease with no pharmaceutical treatment options. It's a ...

Endpoints · 1d agoNeutral↗ source

Updated: GSK reveals three-year blueprint to cut costs and propel R&D

Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans for a three-year cost-cutting initiative, the launch of at least ...

Endpoints · 1d agoNeutral↗ source

Updated: Altimmune’s GLP-1-based shot cuts drinking in patients with alcoholism

Altimmune said Tuesday that its GLP-1/glucagon agonist reduced drinking in people with moderate-to-severe alcohol use disorder in a mid-stage study. Patients in the Phase 2 RECLAIM trial took a wee…

Endpoints · 1d agoNeutral↗ source

Yarrow to begin trading as it targets Graves; FDA approves Otsuka's ADHD pill

Plus news about Outlook Therapeutics, Gossamer Bio, Apnimed and Entera Bio. 📈 Yarrow closes merger to go public: Yarrow Bioscience is developing an anti-TSHR antibody for Graves’ disease and thyro…

Endpoints · 2d agoApprovalPositive↗ source