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The Latest Breaking News from FDA

Pharma leaders hope next FDA head calms waters

They called for stability and predictability at the agency at Axios' Future of Health summit.

Axios

PolyPid Q1 Earnings Call Highlights

PolyPid (NASDAQ:PYPD) said its first quarter marked a transition from late-stage clinical development toward regulatory submission and commercial preparation for D-PLEX100, its lead product candidate for preventing surgical site infections in abdominal colorectal surgery. Chief Executive Officer Di

MarketBeat

PDS Biotechnology Q1 Earnings Call Highlights

PDS Biotechnology (NASDAQ:PDSB) reported a smaller first-quarter loss and highlighted changes to its late-stage head and neck cancer trial that management said could shorten development timelines and reduce costs. On the company’s first quarter 2026 earnings call, Chief Executive Officer Dr. Frank

MarketBeat

From analysis to the latest developments in health,
read the most diverse news in one place.

Innate Pharma Q1 Earnings Call Highlights

Innate Pharma (NASDAQ:IPHA) said its first-quarter 2026 business update centered on three priority clinical assets: lacutamab in cutaneous T-cell lymphoma, the Nectin-4 antibody-drug conjugate IPH4502 in advanced solid tumors, and the AstraZeneca-partnered monalizumab program in non-small cell lung

MarketBeat

FDA chief's resignation widens a leadership gap at the nation's health department

Dr. Marty Makary's resignation from his post atop the Food and Drug Administration is widening a leadership gap that already existed at the U.S. Department of Health and Human Services

The Independent UK

Brainsway Q1 Earnings Call Highlights

Brainsway (NASDAQ:BWAY) reported a strong start to 2026, with first-quarter revenue rising 35% year over year as the company expanded placements of its Deep TMS systems and continued to build its recurring revenue base. Chief Executive Officer Hadar Levy said on the company’s earnings call that rev

MarketBeat

Compass Pathways Q1 Earnings Call Highlights

Compass Pathways (NASDAQ:CMPS) said it has begun a rolling New Drug Application submission for COMP360, its investigational psilocybin treatment for treatment-resistant depression, and is preparing for a potential launch by the end of the year if the therapy is approved. On the company’s first-quar

MarketBeat

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Humacyte Q1 Earnings Call Highlights

Humacyte (NASDAQ:HUMA) reported first-quarter 2026 Symvess sales of $0.5 million and outlined a series of commercial, clinical and cost-reduction initiatives aimed at accelerating adoption of its bioengineered vascular products. On the company’s earnings call, President and Chief Executive Officer

MarketBeat

What to know about Kyle Diamantas, the new acting FDA commissioner

The ex-lawyer who Trump described as ‘very talented’ was previously deputy commissioner for food at the FDA

The Guardian - US

FDA Commissioner Marty Makary Resigns After Clashes With White House

U.S. Food and Drug Administration Commissioner Dr. Marty Makary resigned Tuesday after a turbulent 13-month tenure.

International Business Times

What Is Kratom? Substance Linked To Brandon Clarke Arrest Draws Attention

The death of Brandon Clarke has intensified scrutiny on kratom, a controversial plant-based substance linked to health risks & legal debates in the US

International Business Times UK

Makary's exit creates new uncertainty at FDA

His departure won't solve the organizational upheaval and political jockeying that marked much of his tenure.

Axios

Caris Life Sciences Eyes Bigger Oncology Market After IPO as Revenue Jumps 79%

Caris Life Sciences (NASDAQ:CAI) executives said the company is expanding its commercial reach, product pipeline and biopharma partnerships as it looks to build on recent revenue growth following its IPO last June. Speaking at an investor conference, a Caris executive identified by Chief Scientific

MarketBeat

Novo Nordisk A/S Q1 Earnings Call Highlights

Novo Nordisk A/S (NYSE:NVO) said its first quarter of 2026 was marked by rapid uptake of its newly launched Wegovy pill in the U.S., continued expansion of its obesity franchise and a series of pipeline and regulatory milestones, even as adjusted sales declined because of lower realized prices. Chi

MarketBeat

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TriSalus Life Sciences Q1 Earnings Call Highlights

TriSalus Life Sciences (NASDAQ:TLSI) reported slightly lower first-quarter revenue and reduced its full-year 2026 revenue outlook, citing disruption from a broad commercial reorganization and a delayed FDA review for its next-generation TriNav Advance device. President and Chief Executive Officer M

MarketBeat

NeuroPace Q1 Earnings Call Highlights

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

The Guardian - US

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

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news in one place.

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MarketBeat

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

International Business Times UK

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.

MarketBeat

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

Reason

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.

Axios

Marty Makary out as FDA chief

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

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