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The Latest Breaking News from FDA

‘People really need to know’: can we trust beauty products to be safe?

In a shocking new docuseries, the highly unregulated and highly dangerous world of cosmetics is thrust into the spotlight

The Guardian - US

Common dog bowl cleaning mistake putting owners and pets at serious health risk

The Food and Drug Association (FDA) carried out the research to find out more about dog owners' feeding habits and consider the impact of hygiene recommendations on food dish contamination.

Daily Record

FDA Places Clinical Hold On Ocugen's Late-Stage COVID-19 Vaccine Trial

The

Benzinga

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

What's Going On With Myovant Sciences Stock Today?

Myovant Sciences Ltd (NYSE: MYOV) shares are trading significantly lower Tuesday after the company and Pfizer Inc (NYSE: PFE) announced an update on the Supplemental New Drug Application for MYFEMBREE for the manag

Benzinga

FDA Approves BioCardia's Phase 1 Trial With Cell Therapy In COVID-19, Shares Jump

The FDA has signed off BioCardia Inc's (NASDAQ:BCDA) Investigational New Drug (IND) application for BCDA-04 to initiate Phase 1/2 trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. BCDA-04 is a proprietary allogeneic mesenchymal cell (MSC) that is Neurokinin-1 receptor-positive (NK1R+). The trial is expected to start in…

Benzinga

Benzinga's Daily Brief On Trending Tickers For April 12, 2022: Veru, Kohl's Corporation, BioCardia, And More

Benzinga’s “Daily Brief On Trending Tickers” highlights top-searched tickers from around the web and uses the

Benzinga

The Daily Biotech Pulse: Aeglea Stock Jumps On Inherited Metabolic Disease Data, Partial Hold Lifted On Gilead's 2 Blood Trials, Early Data From Novartis' KRAS Inhibitor And More

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

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Here's Why Ocugen Shares Are Falling

Ocugen Inc (NASDAQ: OCGN) shares are trading lower by 5.86% to $2.73 during Tuesday's pre-market session after the company announced that it was informed by the FDA that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN, OCU-002, on clinical hold.

Benzinga

Common dog bowl cleaning mistake that could make you ill as well as your pet

The Food and Drug Administration (FDA) has been investigation dog owners' feeding habits and studying its impact on dog food dish contamination - saying they 'poses significant health risk'

Daily Mirror

FDA Lifts Partial Clinical Hold On Gilead's MDS, AML Magrolimab Studies

The FDA has

Benzinga

Aeglea Bio Stock Gains On Additional Pegzilarginase Data For Rare Metabolic Disease

Aeglea BioTherapeutics Inc (NASDAQ:AGLE) shared additional data from the PEACE Phase 3 study evaluating Pegzilarginase in Arginase 1 Deficiency. Arginase-1 deficiency is a rare inherited disorder characterized by a complete or partial lack of the enzyme arginase in the liver and red blood cells. Arginase plays a role in the breakdown and removal…

Benzinga

Baby formula shortages hit stores across US with some rationing supplies

Product recalls after illnesses and deaths linked to powdered infant formula products combine with supply chain problems

The Guardian - US

Melatonin won't cure your sleep problems — and it might even be harmful

From widely varying melatonin supplement content to limited, temporary efficacy, practicing good sleep hygiene is better for insomnia than melatonin supplements

Inverse

Eton Pharmaceuticals Names James Gruber Finance Chief

Eton Pharmaceuticals Inc (NASDAQ:ETON) has appointed James Gruber as Chief Financial Officer effective immediately. He succeeds Wilson Troutman, who is retiring. Mr. Troutman will remain with the company through May to ensure a smooth transition. Mr. Gruber, most recently, was the U.S. Controller at Horizon Therapeutics (NASDAQ:HZNP) for seven years, where he oversaw…

Benzinga

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news in one place.

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Benzinga

After Leukemia Trial, FDA Puts Partial Hold On Curis' Lymphoma Study

The FDA has placed a partial clinical hold on Curis Inc's (NASDAQ:CRIS) TakeAim Lymphoma study. The TakeAim Lymphoma study is a Phase 1/2 open-label dose-escalating clinical trial investigating emavusertib in patients with B-cell malignancies. This week's notification extends the partial hold across both lymphoma and leukemia studies. As previously announced, the Company had…

Chicago Sun-Times

Can ‘liquid biopsy’ cancer blood tests live up to promise of saving lives?

Research is under way even as one company touts its blood test to people with no signs of cancer as a way to detect tumors that have no recommended screening method.

Benzinga

Veru's Stock Nearly Triples As COVID-19 Drugs Cuts Reduces Deaths By 55% In Hospitalized Patients

Veru Inc (NASDAQ: VERU) has

The Independent UK

Can cancer blood tests live up to promise of saving lives?

A new type of blood test that checks for signs of cancer in healthy people has hit the market

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news in one place.

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Inverse

You're probably handling your pet's food wrong, new study finds

A new study shows how most pet owners don't know or follow FDA food handling guidelines, which could negatively affect human and canine health.

Tribune News Service

Doctors trying to prescribe abortion pills across state lines stymied by legislation

Soon after Dr. Mai Fleming finished her medical residency in the San Francisco Bay Area, she got to work on her Texas medical license. The family medicine doctor had no intention of moving there but invested nine months to master Texas medical law, submit to background checks, get fingerprinted and…

Tribune News Service

Medicare’s strict Alzheimer’s policy raises ante for drugmakers

The U.S. Medicare program’s decision to tightly limit coverage for the first drug meant to slow the course of Alzheimer’s disease has raised the stakes for companies trying to make the next one.

Tribune News Service

Commentary: Medicare is cleaning up the FDA’s mess on Biogen’s Alzheimer’s drug

Medicare has decided once and for all not to pay for Biogen’s new Alzheimer’s drug Aduhelm unless patients are enrolled in a clinical study.

Benzinga

Needham Sees Clear View Into STAAR Surgical's Durable Double-Digit Revenue Expansion

Needham is initiating coverage on STAAR Surgical Company (NASDAQ:STAA) with a Buy rating and an $87 price target. The analysts note that FDA approval of STAA's EVO Implantable Collamer Lens (ICLs) should serve as a meaningful tailwind for revenue. The Company generates most of its revenue from outside US markets. But after the FDA approval…

Benzinga

Is The UK Becoming A Global Center For Psychedelic Medicine?

This article by Freddie Earlam was originally published on Microdose and appears here with permission. If the industry-defining research already conducted at UK centers such as Imperial College, King’s college or even Exeter University’s recent Ketamine Research isn’t enough to convince you, then two more crucial factors surely will. Firstly, a new ‘accelerated pathway’ has…

Benzinga

Zynex Tightens Q1 Sales, EBITDA Guidance; CM-1600 Blood & Fluid Monitor Awaits FDA Approval

Zynex Inc (NASDAQ:ZYXI) expects Q1 FY22 sales of $30.5 million - $31.5 million, approximately 26% higher than Q1 2021, in line with the consensus of $31.04 million. Earlier, the Company had forecasted sales of $29 million - $32 million. The Company expects adjusted EBITDA between $3 million - $4 million versus the prior…

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