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The Latest Breaking News from FDA

Is Co-Diagnostics National Security’s Next Diagnostic Pick?

Global health emergencies are shifting sovereign biodefense strategies toward decentralized diagnostic networks capable of deploying rapid stockpiles.

MarketBeat

FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test

SINGAPORE, May 28, 2026 /PRNewswire/ -- Gene Solutions, a global biotechnology company advancing accessible genomic solutions for cancer detection and precision oncology, today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SPOT-MAS 10, its multi-omic blood test designed to detect cancer-associated signals....

AAP

Lyell Immunopharma Targets 2027 FDA Filing as CAR-T Pipeline Advances

Lyell Immunopharma (NASDAQ:LYEL) President and CEO Lynn Seely outlined the company’s clinical development priorities, regulatory strategy and manufacturing plans during a Stifel investor session moderated by Stephen Willey, senior biotech analyst at Stifel. Seely described Lyell as a cell therapy c

MarketBeat

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CGBIO Signs Global Clinical and Exclusive Commercialization Agreement for NOVOSIS in the U.S., Canada and Australia

SEOUL, South Korea, May 27, 2026 /PRNewswire/ -- CGBIO, a regenerative medicine company (CEO: Hyunseung Yu), announced that it has entered into a global clinical development and exclusive commercialization agreement with DePuy Synthes, a global orthopaedics solutions company, for the NOVOSIS bone graft substitute product portfolio in the United States,…

AAP

IDEAYA Biosciences Spotlights Darovasertib Win, FDA Review Path at Oncology Summit

IDEAYA Biosciences (NASDAQ:IDYA) executives highlighted recent clinical progress across the company’s oncology pipeline during a fireside chat at TD Cowen’s seventh annual Oncology Innovation Summit, with the discussion focused primarily on darovasertib combinations in uveal melanoma and several ear

MarketBeat

The product was sold at Walmart stores across the US

The Independent UK

Coffee, tea and boba products recalled in 25 states over health risk

The drink mixes contained a dry milk powder that was recalled last month in the US

The Independent UK

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EyePoint Pharmaceuticals Eyes Transformative 2026 as DURAVYU Phase 3 Data Nears

Eyepoint Pharmaceuticals (NASDAQ:EYPT) executives said the company remains on track to report top-line data from its Phase 3 wet age-related macular degeneration program for DURAVYU, also known as EYP-1901, beginning in August, with a second pivotal trial expected to follow about two months later.

MarketBeat

Just 1 World Record at the Enhanced Games Shows the Integrity of the Competition

I watched hours and hours of the Enhanced Games so you didn’t have to.

Reason

Karyopharm Therapeutics Teases ASCO SENTRY Data as FDA Path Comes Into Focus

Karyopharm Therapeutics (NASDAQ:KPTI) executives said the company expects to provide a fuller presentation of its Phase 3 SENTRY trial data for selinexor in myelofibrosis at the upcoming ASCO conference, while also outlining expected regulatory engagement and other development priorities during a re

MarketBeat

Disc Medicine Eyes Mid-2026 Bitopertin Approval as EPP Trial Demand Surges

Disc Medicine (NASDAQ:IRON) Chief Executive Officer John Quisel said patient demand for the company’s bitopertin program in erythropoietic protoporphyria, or EPP, remains strong after the company enrolled 183 patients in the APOLLO confirmatory study, above its original target of 150. Speaking at a

MarketBeat

Opus Genetics Touts Retinal Gene Therapy Pipeline, September BEST1 Data Catalyst

Opus Genetics (NASDAQ:IRD) is advancing a portfolio of gene therapies for inherited retinal diseases, with two programs already in the clinic and three more expected to enter clinical testing within the next 12 months, President Dr. Ben Yerxa said during a fireside chat at RBC Capital Markets’ 2026

MarketBeat

Inovio Pharmaceuticals Shareholders Back Board as INO-3107 FDA Review Advances

Inovio Pharmaceuticals (NASDAQ:INO) shareholders approved all proposals presented at the company’s 2026 annual meeting, including the election of eight directors and the ratification of Ernst & Young LLP as the company’s independent registered public accounting firm for the year ending Dec. 31,

MarketBeat

Incyte Sets Mid-Year Phase 3 Trial for CALR Antibody 989 as Pipeline Updates Roll Out

Incyte (NASDAQ:INCY) Chief Medical Officer Steven Stein outlined the company’s development priorities across hematology, oncology and immunology, with a particular focus on its mutant CALR antibody 989, during a company news event. Stein said myeloproliferative neoplasms remain “front and center” f

MarketBeat

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MarketBeat

IDEAYA Biosciences Eyes Busy 2026 as Darovasertib Advances Toward FDA Filing

IDEAYA Biosciences (NASDAQ:IDYA) Chief Executive Yujiro Hata said the precision oncology company is preparing for a busy 2026, led by regulatory and clinical milestones for darovasertib in metastatic uveal melanoma and multiple data readouts across its pipeline. Speaking at a Stifel-hosted event, H

MarketBeat

Amylyx Stock: Why the Full Pipeline Story Matters

Amylyx stock has surged on pipeline progress, but investors should understand the risks and long-term catalysts driving AMLX shares

AAP

Informa Markets Puts Bangkok at the Center of Southeast Asia's Pharma Industry, Uniting 400 Exhibitors, Experts from 70 Countries at CPHI South East Asia

BANGKOK, May 24, 2026 /PRNewswire/ -- Informa Markets sets to organise CPHI South East Asia from 8–10 July 2026 at Queen Sirikit National Convention Center under the theme "The Gateway to the ASEAN Pharma Industry." The event is a comprehensive pharmaceutical manufacturing exhibition, technology showcase, and conference for Southeast Asia,…

The Independent UK

Whole Foods soup recalled in 17 states over risk of ‘life-threatening’ allergen

So far, no illnesses have been reported in connection with the soup

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Budget and the Bees

GLP-1 Drugs Could Soon Treat Heart Failure and Peripheral Artery Disease—FDA Approvals Coming

GLP-1 drugs are no longer just weight-loss and diabetes medications. Researchers are now studying whether these blockbuster treatments can help people living with heart failure and peripheral artery disease (PAD), two serious conditions affecting millions of Americans. That shift could reshape how doctors manage cardiovascular disease in the coming years.…

The Independent UK

FDA staff blindsided by org’s about-face on flavored vapes, contradicting MAHA goals

The vaping guidelines bypassed a federally mandated period for public comment and revisions

Budget and the Bees

Peptide Injections Are Booming — But Unapproved Versions May Cause Skin Cancer and Other Risks

From weight loss and anti-aging to faster muscle recovery, peptide injections have exploded across social media, wellness clinics, and telehealth platforms. Influencers promote them as cutting-edge shortcuts for better health, while patients facing long waits or high prices for prescription drugs often look for alternatives. But not all peptide injections…

MarketBeat

Biogen Stock Slides After Trial Miss, But Analysts Stay Bullish

Biogen’s Alzheimer’s drug candidate showed promising tau-targeting results despite missing a primary endpoint, reinforcing long-term optimism for BIIB stock

MarketBeat

CorMedix Eyes REZZAYO Expansion as DefenCath Reimbursement Shift Looms

CorMedix (NASDAQ:CRMD) CEO Joe said the company is preparing for several potential commercial and regulatory catalysts across its infectious disease and dialysis-related portfolio, including a possible expansion of REZZAYO into fungal infection prophylaxis and continued work to sustain DefenCath uti

MarketBeat

Connect Biopharma Touts Rademikibart’s Edge as SEABREEZE Data Looms in 2026

Connect Biopharma (NASDAQ:CNTB) Chief Executive Officer Barry Quart said the company’s rademikibart program continues to show a differentiated clinical and mechanistic profile as the company awaits mid-2026 data from its SEABREEZE study. Speaking during a fireside chat with H.C. Wainwright analyst

MarketBeat

Black Diamond Therapeutics Lung Cancer Drug Shows 15.2-Month PFS in Phase 2 Study

Black Diamond Therapeutics (NASDAQ:BDTX) reported updated Phase 2 data for silevertinib in treatment-naive non-small cell lung cancer patients with EGFR Non-Classical Mutations, saying the investigational therapy produced a preliminary median progression-free survival of 15.2 months in the study coh

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