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The Latest Breaking News from FDA

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.

MarketBeat

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 Independent UK

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 Economic Times

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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 Independent UK

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…

The Economic Times

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,

MarketBeat

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…

Grocery Coupon Guide

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The FDA Is Now Fast-Tracking Magic Mushroom Drugs for Depression, Joe Rogan Claims Credit for the Idea

Donald Trump signed an order speeding FDA research on psychedelic mental health treatments after a Joe Rogan text, drawing industry praise and scientific caution.

International Business Times UK

Wockhardt shares rocket 19% after FDA approval for antibiotic targeting drug-resistant infections. Check details

Wockhardt's shares surged 19% after the U.S. FDA approved ZAYNICH, a novel intravenous antibiotic for complicated urinary tract infections. The drug, combining cefepime and zidebactam, demonstrated superior efficacy over meropenem in a Phase 3 trial. This approval addresses the growing challenge of antimicrobial resistance.

The Economic Times

GRAIL’s Galleri Test Cuts Stage 4 Cancer Diagnoses in Study Despite Missed Endpoint

GRAIL (NASDAQ:GRAL) said new data presented at the American Society of Clinical Oncology annual meeting showed its Galleri multi-cancer early detection blood test can identify more cancers through screening and reduce stage 4 diagnoses, though the company confirmed that a primary endpoint in its lar

MarketBeat

Oculis Shelves FDA Filing After Phase 3 DME Trials Miss Key Vision Goals

Oculis (NASDAQ:OCS) said its two Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema did not meet their primary endpoints, and the company does not currently plan to pursue a U.S. Food and Drug Administration filing for the drug candidate in that indication. Chief Executive Officer Riad Sher

MarketBeat

I started using these 13 skincare products after 50, and they really work

I incorporated these beauty devices, sunscreens and serums into my new skincare regimen, which helped with fine lines and skin protection

The Guardian - US

MannKind Wins FDA Approval for Afrezza in Children, Opening Pediatric Diabetes Market

MannKind (NASDAQ:MNKD) said the U.S. Food and Drug Administration has approved Afrezza for pediatric patients with diabetes ages 6 and older, expanding the inhaled mealtime insulin’s label into children and adolescents. Chief Executive Officer Michael Castagna called the decision “a truly historic

MarketBeat

Popular ice pops recalled over risk of ‘life-threatening’ allergic reaction

The recalled sweet treats were distributed to grocery stores in four states

The Independent UK

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MarketBeat

Alpha Tau Medical Sets Up Catalyst-Rich 2026 as Key Cancer Trial Data Nears

Alpha Tau Medical (NASDAQ:DRTS) outlined a series of clinical and regulatory updates during the Lytham Partners Spring 2026 Investor Conference, with Raphi Levy of Alpha Tau telling investors the company’s most important trials are “coming to a head” over the coming months. Levy said the company is

The Economic Times

U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plant

The U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Findings revealed risks of microbiological contamination, falsified records, and the presence of live birds and droppings in a raw material warehouse. Management also failed to review production records before batch…

Medical Daily

FDA Approves New Immunotherapy Combination for High-Risk Early-Stage Bladder Cancer

The U.S. Food and Drug Administration (FDA) has approved a new treatment option for patients with high-risk non–muscle invasive bladder cancer (NMIBC), authorizing the use of durvalumab (Imfinzi) in combination with Bacillus Calmette-Guérin (BCG) on May 28, 2026.

MarketBeat

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.

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AAP

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....

MarketBeat

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

AAP

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,…

MarketBeat

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

The Independent UK

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

MarketBeat

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.

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