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The Latest Breaking News from FDA

CG Oncology BLA Filing on Track as Key Bladder Cancer Data Nears

CG Oncology (NASDAQ:CGON) executives said the company remains on track to complete a rolling biologics license application for cretostimogene in BCG-unresponsive high-risk non-muscle invasive bladder cancer by the fourth quarter, while reiterating expectations for top-line data from a separate Phase

MarketBeat

Supreme Court preserves telemedicine access to abortion drug

The Supreme Court on Thursday allowed access to medication abortion via telemedicine and by mail to continue, blocking a decision at the appellate court level that had restricted the drug. The justices granted emergency requests from the makers of mifepristone, Danco Laboratories LLC and GenBioPro Inc., after the New Orleans-based…

Roll Call

What Do Bruen, Dobbs, and SFFA Have In Common?

The Supreme Court issued landmark rulings that were resisted by lower courts, and the Supreme Court refused to intervene.

Reason

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Eton Pharmaceuticals Q1 Earnings Call Highlights

Eton Pharmaceuticals (NASDAQ:ETON) raised its 2026 revenue outlook after reporting record first-quarter product sales and highlighting early progress from two recent product launches, DESMODA and HEMANGEOL. Chief Executive Officer Sean Brynjelsen said the company now expects full-year revenue to ex

MarketBeat

CapsoVision Q1 Earnings Call Highlights

CapsoVision (NASDAQ:CV) reported steady first-quarter revenue and said it continues to advance artificial intelligence and capsule endoscopy programs aimed at expanding the use of its gastrointestinal imaging platform. On the company’s first-quarter 2026 earnings call, President and Chief Executive

MarketBeat

Celcuity Q1 Earnings Call Highlights

Celcuity (NASDAQ:CELC) reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer. On the company

MarketBeat

Supreme Court allows abortion pill access while lawsuit proceeds

The widely expected order provides legal certainty for pharmacies, telehealth companies and clinicians.

Axios

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Supreme Court preserves access to abortion drug mifepristone while legal battle continues

Justices block nationwide ban on mail-order and telehealth access to widely used abortion pill while high-profile legal challenge continues

The Independent UK

Supreme court allows abortion pill mifepristone to continue to be available by mail

Louisiana had sued the FDA in a bid to curtail the regulatory agency’s rules on prescribing mifepristone remotely

The Guardian - US

Bicara Therapeutics Touts Cancer Drug Progress Ahead of 2026 Pivotal Data

Bicara Therapeutics (NASDAQ:BCAX) said its lead cancer drug candidate, ficerafusp alfa, remains on track for pivotal data in head and neck cancer in mid-2026, as the company outlined its development strategy and competitive positioning at the Bank of America Healthcare Conference. Ryan Kohlhepp of

MarketBeat

Karyopharm Therapeutics Q1 Earnings Call Highlights

Karyopharm Therapeutics (NASDAQ:KPTI) said it entered 2026 with several near-term clinical and regulatory catalysts, led by new Phase 3 data in myelofibrosis and an expected midyear readout in endometrial cancer, while reporting higher first-quarter revenue and reaffirming full-year guidance. On th

MarketBeat

CorMedix Q1 Earnings Call Highlights

CorMedix (NASDAQ:CRMD) reported sharply higher first-quarter 2026 revenue and profit, driven by continued adoption of DefenCath and the addition of products from its Melinta acquisition, while management raised its full-year financial outlook and outlined key pipeline developments. Chairman and Chi

MarketBeat

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

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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

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

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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

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

Axios

Pharma leaders hope next FDA head calms waters

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

MarketBeat

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

The Independent UK

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

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