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The Latest Breaking News from FDA

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?

The Guardian - UK

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

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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

MarketBeat

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…

Budget and the Bees

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

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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

MarketBeat

Why Bearing Selection Is One of the Most Overlooked Decisions in Food Manufacturing

Bearing selection in food manufacturing impacts uptime, safety, and compliance. Food-grade and ceramic hybrid bearings help improve durability and reduce downtime in demanding production environments.

inkl

Kroger Cheese Garlic Croutons Recall: FDA Warns Product Tied to Toxic Milk Powder

Kroger Cheese Garlic Croutons have been recalled across several US states over a salmonella risk linked to milk powder in their seasoning, with no illnesses reported but specific batches withdrawn.

International Business Times UK

Federal Watchdog Finds Nursing Homes Sedating Dementia Patients with Antipsychotics — and Calls for a Crackdown

Families place loved ones in nursing homes expecting safety, dignity, and compassionate care. But alarming new federal watchdog reports suggest that some facilities are relying...

Saving Advice

Urgent recall of croutons sold at Kroger over health risk

Affected products were sold at the grocery chain’s stores in 17 states

The Independent UK

Agios Pharmaceuticals Touts Strong AQVESME Launch as Sickle Cell Filing Advances

Agios Pharmaceuticals (NASDAQ:AGIO) executives said the company is focused on advancing mitapivat across rare hematologic diseases, highlighting early launch traction in thalassemia and a recently submitted supplemental new drug application for sickle cell disease during a presentation at the 2026 R

MarketBeat

The Apple Watch Ultra 4 is tipped to get a new way to keep your heart healthy — but there’s a catch

The Apple Watch Ultra 4 might get a new blood pressure alert feature, a report claims.

TechRadar

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Budget and the Bees

Home HPV Screening Is Here: FDA-Approved Teal Wand Detects 14 High-Risk Strains — Who Qualifies and How to Order

Home HPV screening is no longer a future concept reserved for clinical trials or healthcare headlines. The FDA-authorized Teal Wand allows eligible patients to collect a sample at home and test for 14 high-risk HPV strains linked to cervical cancer. For people who delay screenings because of busy schedules, transportation…

The Independent UK

MAGA runs on ZYN: Nicotine pouches become all the rage with Trump admin including the health secretary RFK Jr

Kennedy has publicly endorsed the popular product, calling it ‘probably the safest way to consume nicotine’

Budget and the Bees

‘Desire Doesn’t Expire’: The Pink Pill Addyi Now Approved for Women up to 65 — What to Know About the New Approval

For years, many women entering menopause or postmenopause were told that declining sexual desire was simply part of aging. Now, a major FDA decision is changing that conversation after Addyi, often called the “pink pill,” received expanded approval for women under 65, including postmenopausal women. The drug, known generically as…

MarketBeat

NRx Pharmaceuticals Q1 Earnings Call Highlights

NRx Pharmaceuticals (NASDAQ:NRXP) said it advanced several regulatory, manufacturing and clinical initiatives during the first quarter of 2026, including progress toward potential approval of its preservative-free ketamine product, KETAFREE, and preparations for an NDA filing for NRX-100. Founder,

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MarketBeat

Gossamer Bio Q1 Earnings Call Highlights

Gossamer Bio (NASDAQ:GOSS) said it is moving ahead with plans to seek U.S. approval for seralutinib in pulmonary arterial hypertension, outlining a September 2026 target for a New Drug Application submission while also detailing new imaging data and steps to address its balance sheet during its firs

The Conversation

Flavored vapes led to a major shake-up at the FDA – 3 health policy analysts explain the science behind the controversial products

The resignation of Marty Makary, commissioner of the U.S. Food and Drug Administration, on May 12, 2026, brought to the forefront a heated controversy over fruit-flavored nicotine vapes.

MarketBeat

iRhythm Technologies Touts Medicare Win, Zio Growth and AI-Driven Margin Gains

iRhythm Technologies (NASDAQ:IRTC) executives said the company is seeing continued business momentum after a favorable Medicare coverage update, a stronger-than-expected first quarter and progress on several product and margin initiatives. Speaking at an investor event, Stephanie Zhadkevich, senior

MarketBeat

Incyte CEO Says Post-Jakafi Growth Path Is Clearer as Pipeline Catalysts Build

Incyte (NASDAQ:INCY) President and CEO Bill Meury said the company’s post-Jakafi growth profile has become “much clearer” over the past year, pointing to continued growth in its commercial business, late-stage pipeline activity and potential launches across oncology and immunology. Speaking at the

The Independent UK

Doctors explain why maggot therapy is still a leading treatment in the US

The FDA approved medical use of ‘nature’s microsurgeons’ more than 20 years ago

MarketBeat

GRAIL Says Galleri Demand Is Rising as NHS Talks, FDA Review Move Ahead

GRAIL (NASDAQ:GRAL) said demand for its Galleri multi-cancer early detection test has continued to grow despite recent headlines related to its NHS study, according to comments made by Aaron, who identified himself during the discussion as the company’s CFO, at a Bank of America event. Aaron said t

MarketBeat

Erasca Touts 'Eye-Popping' ERAS-0015 Lung Cancer Data, FDA Path at BofA Conference

Erasca (NASDAQ:ERAS) executives said the company sees multiple potential development paths for its RAS-targeting portfolio, highlighting early clinical activity for ERAS-0015 in lung, pancreatic and colorectal cancers during a Bank of America biotech conference session. Jonathan Lim, Erasca’s chair

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