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The Latest Breaking News from FDA

NeuroPace (NASDAQ:NPCE) raised its 2026 revenue outlook after reporting first-quarter results that management said reflected continued demand for its RNS System and improving commercial execution across epilepsy treatment centers. The company reported total revenue of $22.1 million for the first qu

MarketBeat

Spectral AI Q1 Earnings Call Highlights

Spectral AI (NASDAQ:MDAI) said it remains on track toward potential U.S. regulatory clearance and commercialization of its DeepView system for burn assessment, while reporting lower first-quarter research and development revenue tied to the completion of work under a federal contract. On the compan

MarketBeat

Trump news at a glance: despite presidential pressure, some Republicans in South Carolina take stand against redistricting

Five Republicans joined all Democrats in the state senate to reject a redistricting proposal that Trump is pushing for – key US politics stories from Tuesday 12 May at a glance

The Guardian - US

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Hyperfine Q1 Earnings Call Highlights

Hyperfine (NASDAQ:HYPR) reported a sharp year-over-year increase in first-quarter revenue and reiterated its full-year 2026 outlook, as management pointed to continued adoption of its next-generation Swoop portable MRI system across hospitals, neurology offices and international markets. President

MarketBeat

Fractyl Health Q1 Earnings Call Highlights

Fractyl Health (NASDAQ:GUTS) said it remains on track to report pivotal data for its Revita therapy in early fourth quarter 2026, as management highlighted clinical, regulatory and reimbursement developments during the company’s first-quarter 2026 earnings call. Chief Executive Officer Dr. Harith R

MarketBeat

Did Trump Fire Marty Makary? The Mango Vape Battle That 'Helped Push' FDA Commissioner Out the Door

Marty Makary resigned as FDA Commissioner amid disputes over mango-flavoured vapes, with speculation that political pressure from Trump influenced his departure.

International Business Times UK

Capricor Therapeutics Q1 Earnings Call Highlights

Capricor Therapeutics (NASDAQ:CAPR) said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku. On t

MarketBeat

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Marty Makary's Irrational Resistance to Flavored Nicotine Vapes Drove His FDA Resignation

On the subject of tobacco harm reduction, the former commissioner let his emotions override his avowed commitment to following the science.

Reason

Patients Have a Right To Try. Why Can't They Use It?

Terminally ill patients were promised access to experimental treatments, but the "right to try" exists mostly on paper.

Reason

Marty Makary out as FDA chief

His tenure was marked by organizational upheaval, controversies over drug approvals and tensions with the White House.

Axios

Marty Makary departs FDA after clashes with Trump over fruit-flavored vapes

Kyle Diamantas, a top official at the agency, will replace Makary and serve as acting FDA commissioner

The Guardian - US

SAB Biotherapeutics Q1 Earnings Call Highlights

SAB Biotherapeutics (NASDAQ:SABS) said its lead type 1 diabetes candidate, SAB-142, remains on track in a registrational Phase 2b trial, as the clinical-stage biopharmaceutical company reported a wider first-quarter loss alongside higher research and development spending. Chief Executive Officer Sa

MarketBeat

Makary out at FDA after facing pressure to resign

Food and Drug Administration Commissioner Marty Makary will leave his role, President Donald Trump said Tuesday. Makary’s departure comes after pressure within the administration to step down over a variety of issues, from abortion medication to flavored vapes. FDA Deputy Commissioner for Food Kyle Diamantas will lead the agency in an acting capacity. He…

Roll Call

Target snack mix among products recalled over potential salmonella contamination

The recall includes a Good & Gather product that was sold at Target stores across the US

The Independent UK

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MarketBeat

Arvinas Q1 Earnings Call Highlights

Arvinas (NASDAQ:ARVN) said its first quarter was marked by the FDA approval of VEPPANU, a new licensing agreement with Rigel Pharmaceuticals and continued progress across a clinical-stage pipeline focused on targeted protein degradation. President and Chief Executive Officer Randy Teel said the app

MarketBeat

Achieve Life Sciences Q1 Earnings Call Highlights

Achieve Life Sciences (NASDAQ:ACHV) used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027. Dr. Andrew Goldbe

Euronews

Europe’s best-performing stocks of 2026 — including one up by 947%

From Swedish photonics to French satellites and British fuel cells, meet this year's top-performing equities across sectors.

MarketBeat

Hims & Hers Health Q1 Earnings Call Highlights

Hims & Hers Health (NYSE:HIMS) reported first-quarter 2026 revenue growth and raised its full-year revenue outlook, while executives said a strategic shift in the company’s weight-loss business is creating short-term margin pressure and volatility in GAAP results. On the company’s earnings call

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MarketBeat

aTyr Pharma Revamps Efzofitimod Path With New Phase III Sarcoidosis Trial

aTyr Pharma (NASDAQ:ATYR) said it plans to conduct a new Phase III trial of efzofitimod in pulmonary sarcoidosis after receiving feedback from the U.S. Food and Drug Administration at a recent Type C meeting. President and CEO Dr. Sanjay Shukla said the meeting, held in mid-April with official minu

Latin Times

Report: FDA Commissioner Set To Be Fired, Sources Say Trump Could Still Change His Mind

Makary is scheduled to testify before the Senate Appropriations Committee on May 13 on the FDA's budget for the coming fiscal year. He was appointed to his post last year.

The Economic Times

Hims earnings today: Why Hims & Hers Health stock dropped despite raising revenue forecast - here's what investors need to know

Hims stock after Hims & Hers earnings: Hims & Hers Health shares dropped significantly after reporting a surprise first-quarter loss and revenue below expectations. Despite these weak results, the company raised its full-year revenue outlook and projected strong second-quarter revenue, as it navigates regulatory scrutiny around weight-loss drugs.

Reason

Justice Alito Extends Administrative Stay of Mifepristone Order

The justices will consider what to do with the Fifth Circuit's mifepristone order for af ew more days

International Business Times

Supreme Court Maintains Temporary Mail Access To Abortion Pill Mifepristone

The Supreme Court extended temporary mail access to abortion pill mifepristone on Monday.

The Guardian - US

US supreme court temporarily extends access to mail-order abortion medication mifepristone

Louisiana had sued the FDA last fall, arguing that prescribing mifepristone interfered with state’s ban on abortion

MarketBeat

Alpha Tau Medical Shares Early REGAIN Data: 2 Complete Responses in Glioblastoma Study

Alpha Tau Medical (NASDAQ:DRTS) presented early clinical results from the first three patients treated in its REGAIN study of Alpha DaRT for recurrent glioblastoma, with company executives and clinical investigators describing initial tumor responses and safety observations from the pilot trial. Th

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