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The Latest Breaking News from FDA

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

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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

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

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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

MarketBeat

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,…

AAP

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

The Independent UK

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.…

Budget and the Bees

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

The Independent UK

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…

Budget and the Bees

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

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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

The Guardian - UK

Enhanced Games explained: sport’s most controversial event unpacked

Why are the Enhanced Games, taking place in Las Vegas this weekend, so contentious, and how have governing bodies have responded to the event?

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MarketBeat

Compass Pathways Eyes Q4 FDA Filing for Psilocybin Depression Drug After Phase 3 Wins

Compass Pathways (NASDAQ:CMPS) executives said the company remains on track to target a fourth-quarter New Drug Application filing for COMP360, its synthetic psilocybin treatment candidate for treatment-resistant depression, while preparing commercially for a potentially accelerated regulatory timel

MarketBeat

Belite Bio Q1 Earnings Call Highlights

Belite Bio (NASDAQ:BLTE) said it has begun a rolling New Drug Application submission to the U.S. Food and Drug Administration for Tinlarebant in Stargardt disease, while also accelerating preparations for a potential commercial launch. On the company’s first-quarter 2026 earnings call, Chairman and

MarketBeat

Beam Therapeutics Eyes Sickle Cell BLA as Alpha-1 Gene-Editing Program Advances

Beam Therapeutics (NASDAQ:BEAM) Chief Executive Officer John Evans said the company is advancing its base-editing platform across hematology and liver disease programs, with a potential biologics license application for its sickle cell disease candidate possible as early as the end of this year. Sp

Budget and the Bees

Chronic UTIs, Meet Your Match: New FDA-Approved Fosfomycin Injection Shows 64% Success Against Complicated Infections

For people trapped in the exhausting cycle of chronic urinary tract infections, every new symptom can feel like a setback. Repeated antibiotics, emergency visits, and infections that keep returning can take a serious toll on daily life. Now, a newly FDA-approved fosfomycin injection is offering fresh hope for adults battling…

MarketBeat

Mirum Pharma: A Rare Disease Growth Story to Watch

Mirum stock pulled back after earnings despite strong growth. Here’s why investors still see upside in the rare disease biotech company

MarketBeat

Roivant Sciences Q4 Earnings Call Highlights

Roivant Sciences (NASDAQ:ROIV) executives used the company’s fourth-quarter earnings call to highlight new open-label data for IMVT-1402 in difficult-to-treat rheumatoid arthritis, upcoming pulmonary hypertension data for mosliciguat and continued preparation for a potential brepocitinib launch in d

MarketBeat

Immunovant Q4 Earnings Call Highlights

Roivant executives used the company’s fourth-quarter and fiscal-year earnings call to highlight new clinical data from its development portfolio, upcoming readouts and its strengthened balance sheet following a settlement with Moderna. Matthew Klein, CEO of Roivant, said the company has had “a pret

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