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The Latest Breaking News from FDA

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

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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

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

The Independent UK

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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

MarketBeat

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…

The Economic Times

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.

Medical Daily

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

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

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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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Reason

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.

MarketBeat

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

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

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