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The Latest Breaking News from FDA

This ‘Strong Buy’ Stock Has More Than Tripled Today. Should You Buy It Here?

Praxis shares soar as the biotech firm reports promising late-stage results for ulixacaltamide. Here’s why it may not be too late to invest in PRAX shares.

Barchart

Novartis Strengthens Kidney Disease Pipeline With Promising Data

Novartis A/S (NYSE:NVS) on Thursday shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).

Benzinga

16 cinnamon brands to avoid after high levels of lead found in spice blends

Four brands have been added to the FDA’s ongoing health alert within the last week

The Independent UK

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There have currently been no reported illnesses as a result of the contamination, the FDA reports

The Independent UK

Powering up? Unsafe levels of lead found in top protein powder mixes, study finds

Supplements like protein powders are not regulated by the U.S. Food and Drug Administration

The Independent UK

10 Children’s Medications That Were Recently Recalled

Image source: shutterstock.com

Kids Ain't Cheap

FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate

The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.’s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

Benzinga

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FDA Acceptance Of Rocket Pharmaceuticals' Lead Gene Therapy Application Reestablishes Momentum For Stock

On Tuesday, the U.S. Food and Drug Administration (FDA) accepted Rocket Pharmaceuticals, Inc.’s (NASDAQ:RCKT) resubmission of the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; marne-cel), a lentiviral vector (LV)-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I).

Benzinga

Telix Pharmaceuticals Enters Q4 On Strong Footing With Stabilized Pricing Pressures, Upgraded Annual Sales Guidance

Telix Pharmaceuticals (NASDAQ:TLX) updated on Tuesday its commercial and operational performance for the third quarter of fiscal 2025.

Benzinga

Simple blood test gets green light by FDA to improve early detection of Alzheimer’s disease

Millions of Americans are living with Alzheimer’s and hundreds of thousands are diagnosed each year

The Independent UK

State urges residents to check freezers for radioactive shrimp after damning investigation into Indonesian farm

FDA has added to list of brands and products that may have been contaminated with cesium-137, a human-made radioactive substance that can cause cancer

The Independent UK

Why Congress Is Buying Intuitive Surgical Ahead of Earnings

Intuitive Surgical has attracted recent congressional buying ahead of its next quarterly earnings results, implying a new potential bull run

MarketBeat

Doritos and Cheetos are getting a makeover with ingredient change — and new flavor line

In addition to new recipes, PepsiCo hopes to introduce fresh packaging for its beloved snacks

The Independent UK

Depression-Focused GH Research Shares Could See Significant Upside: Analyst

Needham initiated coverage on Monday for GH Research PLC (NASDAQ:GHRS), citing the company’s lead drug candidate, GH-001, which had demonstrated impressive efficacy in Phase 2 versus competition.

Benzinga

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Benzinga

Why Is Scholar Rock Stock Trading Lower On Monday?

Scholar Rock Holding Inc. (NASDAQ:SRRK) stock is falling on Monday with a session volume of 8.19 million versus the average volume of 2.08 million, as per data from Benzinga Pro.

Saving Advice

10 Foods That Interfere with Common Senior Medications

As people age, prescription use increases—but few realize that certain everyday foods can make those medications less effective or even dangerous. The Centers for Disease...

Benzinga

FDA Adds New Warning For Johnson & Johnson's Cancer Cell Therapy

The Food and Drug Administration (FDA) has updated safety labeling for Johnson Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.

International Business Times UK

Sam Altman-Backed Arcadia Medicine Gets FDA Nod for Trials on 'Healthier' Ecstasy Formula

San Francisco biotech Arcadia Medicine, backed by Sam Altman, wins FDA nod to trial AM-1002, a safer MDMA variant to treat anxiety.

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The Independent UK

Company backed by Sam Altman gets FDA approval to trial ‘legal ecstasy’

Clinical trials of ‘safer MDMA’ could lead to new way of treating mental health problems, biotech firm says

Reason

N.Y. Federal Court Upholds "Algorithmic Pricing Disclosure Act"

From Nat'l Retail Fed'n v. James, decided yesterday by Judge Jed Rakoff (S.D.N.Y.): [T]he Algorithmic Pricing Disclosure Act … provides… The post N.Y. Federal Court Upholds "Algorithmic Pricing Disclosure Act" appeared first on Reason.com.

Reason

Original Zyn: FDA Failures Allow Fake Nicotine Pouches To Flood U.S. Market

By refusing to approve safer nicotine pouches, regulators have turned gas stations into gray markets for knockoffs.

Saving Advice

Breakthrough Alzheimer’s Drug Could Reshape Senior Care

A new Alzheimer’s drug is offering hope where few options once existed. Recently approved by the FDA, it’s the first treatment shown to slow cognitive...

Benzinga

Regeneron's Libtayo Gains FDA Approval To Reduce Recurrence Risk In Skin Cancer Patients

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

Benzinga

Tempus AI's $100 Breakout — Billionaire Cliff Asness Reaps 60% Windfall

Tempus AI Inc (NASDAQ:TEM) has become one of 2025's most dramatic comeback stories. The stock soared past $100 this week, marking a new 52-week high and sending the market buzzing about the AI-powered cancer diagnostics company's growth prospects. Investors are taking note as the stock climbs amid recent FDA clearances…

Benzinga

FDA Expands Johnson & Johnson Ulcerative Colitis Drug Approval To Pediatric Patients

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg.

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