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The Latest Breaking News on Pharma

Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

Benzinga

FDA reaches "tipping point" after high-level departures

Biotech and pharmaceutical companies rely on the FDA for guidance as they spend huge sums developing treatments.

Axios

Why UiPath Shares Are Trading Higher By Around 9%; Here Are 20 Stocks Moving Premarket

Shares of UiPath Inc. (NYSE:PATH) rose sharply in pre-market trading after the company reported upbeat third-quarter financial results and issued fourth-quarter sales guidance with its midpoint above estimates.

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

Why Are Torrid Holdings (CURV) Shares Falling After Hours?

Torrid Holdings Inc. (NYSE:CURV) shares fell 14.5% to $1.12 in after-hours trading on Wednesday after the retailer reported its third-quarter fiscal results.

Benzinga

These Healthcare Stocks Just Exploded In Momentum — Investors Are Taking Notice

In the pulsating world of healthcare stocks, Elekta Inc. (OTC:EKTAY) has distinguished itself this week with a staggering 129% surge in its momentum score, leaping from 19.90 to 45.67. Elekta, a renowned manufacturer of medical equipment, found its stock trading at $5.86 on Wednesday, unmoved from the previous day’s close but comfortably…

Benzinga

Analyst Says Viridian's New Thyroid Eye Drug Could Outperform Amgen's Tepezza

William Blair initiated coverage on Viridian Therapeutics Inc. (NASDAQ:VRDN) on Wednesday.

Benzinga

Capricor Stock Soars, Shkreli Is Short: Here's What Pharma Bro Had To Say

Capricor Therapeutics, Inc. (NASDAQ:CAPR) stock soared on Wednesday after the company announced positive topline data from the Phase 3 HOPE-3 trial for its lead cell therapy candidate, deramiocel.

Benzinga

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A biotech company is beginning trials for a fentanyl vaccine. The CEO says it ‘could completely change’ how overdoses are treated

Human trials are scheduled to begin in the Netherlands early next year

The Independent UK

The Fastest Tariff U-Turn in History: How Britain Made Trump Blink on Pharmaceuticals

Fastest tariff reversal ever: Britain wins zero-tariff pharma deal as Trump backs down—NHS faces 25% higher drug costs. See effects on patients and jobs.

International Business Times UK

NHS to pay 25% more for innovative drugs after UK–US zero-tariff deal

Agreement could cost NHS an extra £3bn a year, industry sources estimate

The Guardian - UK

Illegal weight-loss drugs being sold in UK by firms with high Trustpilot scores

Exclusive: Guardian investigation finds unlicensed jabs offered as experts call for more online regulation

The Guardian - UK

Weight loss drugs go from niche to mainstream

New pricing deals and aggressive marketing are transforming GLP-1s.

Axios

Ascendis Pharma Hit By FDA Delay As TransCon CNP Decision Slips To 2026

The U.S. Food Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ:ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia.

Benzinga

Why Heartbeam Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

Shares of Heartbeam Inc (NASDAQ:BEAT) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.

Benzinga

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Benzinga

BiomX Awaits FDA Clearance To Restart Cystic Fibrosis Trial After Nebulizer Device Review

BiomX Inc. (NYSE:PHGE) on Tuesday announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the company's Phase 2b trial of BX004 in cystic fibrosis patients.

Benzinga

Valneva Posts Positive Lyme Vaccine Booster Results — Pfizer Targeting 2026 Regulatory Filings

Valneva SE (NASDAQ:VALN) shared final immunogenicity and safety data on Wednesday from the Phase 2 study, VLA15-221, of the Lyme disease vaccine candidate, VLA15.

The Independent UK

Trump administration says lower prices for 15 Medicare drugs will save taxpayers billions

The Trump administration says pharmaceutical companies have agreed to slash the Medicare prices for 15 prescription drugs after months of negotiations and that it's expected to produce billions in savings for older adults

The Independent UK

Enhanced Games to offer performance enhancers ... and stock ... to the public

The no-drug-testing Enhanced Games is going public in two ways — with a new listing on the Nadsaq stock exchange and also by offering a direct-to-consumer business focused on performance products

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Benzinga

Why Pasithea Therapeutics (KTTA) Stock Is Suddenly On Fire Today

Pasithea Therapeutics Corp (NASDAQ:KTTA) shares are trading sharply higher Wednesday morning after a string of upbeat updates on its lead drug candidate, PAS-004, capped by a new $1 million grant from the ALS Association. Here’s what investors need to know.

Benzinga

What's Going On With Johnson & Johnson Stock On Wednesday?

Johnson Johnson (NYSE:JNJ) stock has surged almost 42.9% in the year to date, approximately 35% in 6 months, and 8.6% in one month.

Benzinga

Medicare Announces Price Cuts For 15 Drugs— Novo Nordisk's Wegovy And Ozempic To Cost $274 A Month

The U.S. Centers for Medicare and Medicaid Services (CMS) on Tuesday announced that it has secured lower prices for 15 of its highest‑cost medications, resulting in substantial annual savings on prescription expenses.

International Business Times

David Esposito: The Science of Conviction

ONL's focus on protecting retinal cells from dying rather than replacing them positions it apart from gene-therapy competitors such as Nanoscope and Ray Therapeutics.

Benzinga

AstraZeneca Doubles Down On US Biologics Buildout As Drug Discovery Partnership Grows

Hong Kong-based Harbour BioMed announced on Sunday an update and advancement of its global strategic collaboration with AstraZeneca Plc (NASDAQ:AZN), initially established in March 2025.

Tom’s Hardware

AMD to allegedly raise graphics card prices by at least 10% in 2026 — price surge attributed to ongoing AI-related DRAM supply crisis

AMD has informed its board partners that it will have to raise prices on its graphics cards for 2026 following the recent sky-rocketing memory prices put a supply squeeze on a range of electronics industries.

Benzinga

Why Is Biogen Stock Trading Higher After Semaglutide Alzheimer's Data?

Biogen Inc. (NASDAQ:BIIB) stock traded higher after Novo Nordisk A/S (NYSE:NVO) released disappointing topline results from the 2-year primary analysis of Evoke and Evoke+ phase 3 trials in early-stage symptomatic Alzheimer's disease.

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