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STAT808 Endpoints607 BioPharma Dive231 onclive165 BioSpace77 Fierce Biotech75 raps32 fda press20

therapy area

all Oncology81 Cardiology27 Psychiatry & CNS21 Vaccines17 Immunology17 Rare Disease12 Hepatology

Six key issues we’re watching at Fauci’s hearing
Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
STAT · 18h agoRegulatoryNeutral↗ source
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 · 19h agoRegulatoryNeutral↗ source

page 2 of 62

globenewswire health20

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Infectious Disease4

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The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's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 · 20h 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 · 21h 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 · 23h 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 · 23h 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

Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study

Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…

BioSpace · 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

Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch

If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.

BioSpace · 1d agoRegulatoryNeutral↗ source

Oak Hill takes SPAC track to Nasdaq with Roche asset in tow

Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.

BioSpace · 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 · 14h 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 · 19h 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 · 22h 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