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The Latest Breaking News from FDA

Aquestive Therapeutics Q1 Earnings Call Highlights

Aquestive Therapeutics (NASDAQ:AQST) said it remains on track to resubmit its new drug application for Anaphylm, its epinephrine sublingual film for severe allergic reactions, in the third quarter of 2026, while reporting higher first-quarter revenue and a narrower net loss. On the company’s first-

MarketBeat

Annexon Highlights Q4 Geographic Atrophy Data, GBS Filing Plans at BofA Conference

Annexon (NASDAQ:ANNX) President and CEO Doug Love outlined the company’s late-stage pipeline and regulatory plans during a presentation at the Bank of America Healthcare Conference, highlighting upcoming data in geographic atrophy and regulatory filings for Guillain-Barré syndrome. Love described A

MarketBeat

Amylyx Pharmaceuticals Eyes Phase 3 AVEXITIDE Readout as 2027 Launch Comes Into Focus

Amylyx Pharmaceuticals (NASDAQ:AMLX) is preparing for a pivotal Phase 3 readout for AVEXITIDE, its lead asset for post-bariatric hypoglycemia, or PBH, with data from the LUCIDITY trial expected in the third quarter, Co-Chief Executive Officer Joshua Cohen said at the BofA Annual Healthcare Conferenc

MarketBeat

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QT Imaging Q1 Earnings Call Highlights

QT Imaging (NASDAQ:QTI) reported sharply higher first-quarter 2026 revenue as scanner shipments more than doubled from the prior-year period, while management highlighted progress on reimbursement, regulatory approvals, software upgrades and international expansion during the company’s earnings call

MarketBeat

Omeros Q1 Earnings Call Highlights

Omeros (NASDAQ:OMER) reported first-quarter 2026 net income of $56.1 million, or $0.78 per share, as the company began commercial sales of YARTEMLEA, its recently approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. Chairman and Chief Executive

MarketBeat

Precigen Q1 Earnings Call Highlights

Precigen (NASDAQ:PGEN) reported a sharp increase in first-quarter 2026 revenue as the company’s first commercial product, PAPZIMEOS, continued its U.S. launch following FDA approval in August 2025. On the company’s earnings call, President and CEO Dr. Helen Sabzevari said PAPZIMEOS generated net pr

MarketBeat

Alvotech Plans June FDA Resubmissions, Sees Biosimilar Approvals by Year-End

Alvotech (NASDAQ:ALVO) Chief Strategy Officer Balaji Prasad said the biosimilar developer is preparing to resubmit three biologics license applications to the U.S. Food and Drug Administration in June after addressing manufacturing observations that led to complete response letters for pipeline prod

MarketBeat

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ClearPoint Neuro Q1 Earnings Call Highlights

ClearPoint Neuro (NASDAQ:CLPT) reported record first-quarter 2026 revenue and reaffirmed its full-year outlook, as management highlighted growth in its legacy neurosurgical device business and early contributions from the recently acquired IRRAflow product line. Chief Executive Officer Joe Burnett

MarketBeat

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

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

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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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

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

The Guardian - US

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

International Business Times

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.

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International Business Times UK

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

Axios

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.

MarketBeat

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

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

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