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The Latest Breaking News from FDA

Axsome Therapeutics Readies Auvelity Alzheimer’s Agitation Launch, Expands CNS Pipeline

Axsome Therapeutics (NASDAQ:AXSM) executives said the company is preparing to launch Auvelity in Alzheimer’s disease agitation this month while continuing to expand the drug’s use in major depressive disorder and advance a broad central nervous system pipeline. Speaking at a Jefferies fireside chat

MarketBeat

Avalyn Pharma Outlines Inhaled Fibrosis Push After IPO, With Pivotal Data Ahead

Avalyn Pharma (NASDAQ:AVLN) executives outlined the company’s inhaled pulmonary fibrosis strategy at the Jefferies Global Healthcare Conference, emphasizing its recent IPO, ongoing mid-stage studies and plans to position its candidates as potential backbone therapies for idiopathic pulmonary fibrosi

MarketBeat

Target issues urgent recall of baby wipes sold across the US

Two types of baby wipes have been affected by the recall

The Independent UK

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RFK Jr’s FDA to study if abortion pill mifepristone is safe despite it being on market for over 25 years: report

Roughly 7.5 million women have taken the pill over the past 25 years

The Independent UK

With Nation's Highest Diabetes Rate, San Antonio Faces Major Shift as Medicare Prepares $50 Wegovy Coverage

With diabetes rates among the highest in the U.S., San Antonio could see major change as Medicare's new $50 Wegovy coverage begins July 1, expanding access for eligible residents.

Medical Daily

Almost 15,000 illegal health products seized in Bangkok warehouse raid

A warehouse raid in Bangkok’s Lat Krabang district seeking illegal dietary supplements, cosmetics and herbal products seized nearly 15,000 items worth more than 2 million baht on Friday.

Bangkok Post

Alvotech Nears Inflection Point With 5 U.S. Biosimilars Targeted by Year-End

Alvotech (NASDAQ:ALVO) is at an “inflection point” after more than a decade of investment in its biosimilar platform, Founder and Executive Chairman Róbert Wessman said at the Jefferies Global Healthcare Conference in New York. Speaking with Jefferies analyst Marco Baruzzi, Wessman said Alvotech ha

MarketBeat

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Aldeyra Therapeutics Eyes FDA Feedback as Dry Eye Drug Faces Make-or-Break Moment

Aldeyra Therapeutics (NASDAQ:ALDX) Chief Executive Todd Brady said the company expects near-term feedback from the U.S. Food and Drug Administration on its dry eye disease candidate reproxalap, following a third complete response letter tied to efficacy questions. Speaking at a Jefferies fireside c

MarketBeat

Optellum Celebrates Accelerating Impact in Lung Cancer Care; Now at Over 250 Sites and Growing

OXFORD, United Kingdom and HOUSTON, June 5, 2026 /PRNewswire/ -- Optellum, a leader in AI-enabled lung cancer diagnostics, today announced that it has surpassed 250 clinical sites and analyzed more than 3 million cases to date. This milestone underscores Optellum's commitment to empowering health systems and clinical care teams with…

AAP

"Transformative Advance" in Cancer Treatment Emerges in Dallas — New Pill Shows Rare Survival Jump in Pancreatic Cancer Patients

Pancreatic Cancer treatment may be entering a new era as a breakthrough pill nearly doubles survival in metastatic patients, offering new hope for one of the deadliest forms of cancer.

Medical Daily

I bought peptides with crypto. How my purchase helped fuel a $100 million gray-market, ‘looksmaxxing’ economy

Some of the China-based sellers have pivoted from fentanyl to peptides.

Fortune

20,000 kg sugar-mixed jaggery, coloured peas seized in Pune food safety department raids

The FDA in Pune seized 16 tonnes of jaggery and 20 tonnes of sugar intended for adulteration, alongside 68 kg of artificially coloured fried green peas. Raids also uncovered adulterated flour, hoarded areca nuts, and banned gutka products, with three establishments issued stop-work notices for unhygienic conditions and operating without…

The Economic Times

Amphastar Pharmaceuticals Sees Generic Atrovent Fueling 2026 Growth Despite BAQSIMI Drag

Amphastar Pharmaceuticals (NASDAQ:AMPH) executives told investors at the Jefferies Healthcare Conference that the company is maintaining expectations for mid- to high-single-digit revenue growth in 2026, supported by a new generic launch, Primatene Mist growth and selected API sales from its China b

MarketBeat

MEDIPOST Secures FDA Agreement on Single Pivotal Phase 3 Study with Confirmatory Evidence BLA Filing Strategy for CARTISTEM® in the U.S.

SEOUL, South Korea, June 4, 2026 /PRNewswire/ -- MEDIPOST, a fully integrated commercial stage cell therapy biotechnology company, announced today that it has secured the FDA's agreement to conduct a single pivotal Phase 3 study for CARTISTEM® in the U.S. This milestone marks a significant step forward in MEDIPOST's mission…

AAP

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MarketBeat

MiniMed Group Q4 Earnings Call Highlights

MiniMed Group (NASDAQ:MMED) reported record fiscal 2026 revenue and outlined a slate of product launches it said will support faster growth in fiscal 2027, as management held the company’s first earnings call as a standalone public company following its March IPO. Chief Executive Officer Que Dallar

Budget and the Bees

The Hidden Danger of Summer Sunscreen Ingredients No One Is Talking About

Summer is here, and sunscreen is once again a daily essential for millions of Americans heading to beaches, pools, parks, and backyard cookouts. Most people assume that if a sunscreen product is sitting on a store shelf, it has already been fully proven safe for long-term use. But growing research…

MarketBeat

Medtronic Q4 Earnings Call Highlights

Medtronic (NYSE:MDT) reported what executives described as its strongest top-line performance in a decade, as growth in cardiac ablation, diabetes, medical-surgical products and select neuroscience platforms helped drive fiscal fourth-quarter and full-year results above expectations. Chairman and C

The Independent UK

Health officials sound the alarm over viral ‘Benadryl challenge’ after 5 kids hospitalized in San Diego

At least five kids were sent to Rady Children’s Hospital in San Diego, California, after attempting the challenge

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MarketBeat

Aggressive Insider Buying Signals Opportunity in 3 Risky Stocks

Insiders are betting big on three stocks. Board members, CEOs, and CFOs are among the buyers, signalling confidene in their fundamentals.

The Independent UK

Pizza sold at Costco and Walmart across US recalled over salmonella risk

The pizza product contained a dry milk powder that was recalled in the US in April

The Economic Times

US stocks: Fulcrum shares plummet over 50% after scrapping lead sickle-cell drug on FDA concerns

The oral drug, pociredir, was ‌being tested ⁠to treat sickle-cell ⁠disease, an inherited blood disorder that can trigger pain, anemia and organ damage and reduce life expectancy.

The Independent UK

Pizza recall issued in US over potential salmonella contamination fears

Champion Foods LLC has voluntarily recalled specific batches of Motor City Pizza Co. 5 Cheese Bread across the US due to potential salmonella contamination. The recall stems from an initial California Dairies, Inc. milk powder recall, which is an ingredient in a seasoning blend used in the pizza bread. Despite…

The Economic Times

Wockhardt shares pause massive 36% rally in 5 sessions; slip 7%. What’s behind the selloff?

Wockhardt shares dropped after a recent surge, as investors took profits. This followed the US FDA approval of ZAYNICH, an antibiotic for urinary tract infections. The company also reported a strong turnaround in its March quarter results. Revenue and profit saw significant year-on-year growth. Biotech operations were a key driver…

MarketBeat

Jade Biosciences’ JADE101 Delivers Deep IgA Cuts, Clearing Path for Kidney Trials

Jade Biosciences (NASDAQ:JBIO) said interim results from a Phase 1 healthy volunteer study of JADE101 showed rapid and durable reductions in serum IgA, supporting the company’s plan to advance the antibody into patient studies for IgA nephropathy. Chief Executive Officer Tom Frohlich said JADE101,

Grocery Coupon Guide

Recall Alert: Why Certain Noodle and Snack Products Are Being Pulled from Major Retailers This Week

A recent safety recall has forced several major retailers to pull specific noodle and snack products from their shelves immediately. These items were identified as having a potential contamination issue that could pose a health risk to regular consumers. You should check your pantry right now to see if you…

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