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The Latest Breaking News from FDA

First COVID breath test authorized by FDA

It’s a breath of fresh air.

Tribune News Service

FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples

The Independent UK

FDA approves Covid breathalyzer that can detect cases in three minutes

Device can only be operated by trained professionals

The Independent UK

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

Covaxin’s Phase 2/3 clinical trials put on hold in the US

HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.

The Times of India

Baby formula shortage: What is causing supply issue and which stores are rationing products?

Out-of-stock per centages reached higher than 40 per cent in seven states in first week of April

The Independent UK

Covaxin trials in U.S. put on hold

WHO had announced suspension of the vaccine supplies through UN procurement agencies

The Hindu

Magenta Therapeutics Trims R&D, Cuts Workforce

Magenta Therapeutics Inc (NASDAQ:MGTA) is cutting 14% of staff and axing a planned dosing optimization trial for a stem cell mobilization med, focused on extending its cash runway into Q2 2024. The cost-saving measures focus on shaving administrative expenses and new research investments, including the Company's planned dosing and administration optimization trial…

Benzinga

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Adagio Pauses FDA Emergency Use Request For Its COVID-19 Therapy

Adagio Therapeutics Inc (NASDAQ:ADGI) provided an update on the anticipated timing for its Emergency Use Authorization (EUA) request for adintrevimab (ADG20) for the prevention and treatment of COVID-19. Adintrevimab has demonstrated broadly neutralizing activity in vitro against variants of concern, including Alpha, Beta, Delta, Delta Plus, Gamma, and Omicron BA.1. But, the candidate has markedly…

Benzinga

E-cigs using synthetic nicotine come under FDA oversight

The Food and Drug Administration says it will begin cracking down on e-cigarettes that have used synthetic nicotine to skirt oversight

The Independent UK

Why Lexaria Shares Are Rising Today

Lexaria Bioscience Corp (NASDAQ:LEXX) said that all data analyses from its simulated pulmonary hypertension clinical study HYPER-H21-3 are complete, assessing a single 300mg dose of DehydraTECH-processed cannabidiol (DehydraTECH-CBD). The study findings indicated a tendency (p=0.1) during 15 minutes of simulated low levels of oxygen (hypoxia) for reduced pulmonary artery systolic pressure (PASP)…

Benzinga

The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Booster Data In Kids, Regeneron's COVID-19 Therapy Decision Pushed, Protagonist's Rusfertide Breakthrough Tag Update And More

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

Benzinga

FDA Extends Review Period For Regeneron's COVID-19 Antibody Therapy

The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the…

Benzinga

The FDA approved a new drug to treat Alzheimer's, but Medicare won't always pay for it – a doctor explains what researchers know about Biogen's Aduhelm

Medicare finalized its decision to restrict its coverage of Aduhelm, Biogen’s new Alzheimer’s disease drug, on April 8, 2022.

The Conversation

FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer

Protagonist Therapeutics Inc (NASDAQ: PTGX)

Benzinga

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news in one place.

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Benzinga

Amneal Scores Second US Biosimilars Approval With Alymsys In Oncology

The

Tribune News Service

Outlook poses tough questions for next steps on COVID-19 vaccines

Preparations for another potential round of COVID-19 vaccines are prompting more questions than answers as federal health officials contend with the threat of future variants amid waning public interest in additional shots.

Chicago Tribune

New type of cigarette that ‘helps you smoke less’ debuts in Chicago stores this week, amid some controversy

Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.

Reason

The FDA's Rejection of a Major Vaping Brand Shows It Is Arbitrarily Applying a Nebulous Legal Standard

The agency's obsession with adolescent vaping is driving decisions that undermine public health.

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news in one place.

100’s of premium titles.
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Benzinga

Read Why Pliant Therapeutics Shares Are Soaring Today

Pliant Therapeutics Inc (NASDAQ: PLRX) says that with just two FDA-approved Idiopathic Pulmonary Fibrosis drugs, it believes that is a high unmet need.

Benzinga

Phathom Pharma's Vonoprazan Commercial Preparation Update At Needham Healthcare Conference

At the Needham Healthcare Conference, Phathom Pharmaceuticals Inc (NASDAQ:PHAT) says that licensor Takeda Pharmaceutical Co Ltd (NYSE: TAK) reported Takecab (vonoprazan) Q4 FY21 sales of $221 million and $900 million in FY21. Phathom estimates that around 30% is from erosive esophagitis (EE), approximately 60% is from gastroesophageal reflux disease (GERD)/other, and less than 10% is…

Benzinga

FDA Sends Warning Letters To Online Pharmacies Selling ADHD Drug, Adderall, Illegally

The FDA and the U.S. Drug Enforcement Administration have jointly issued warning letters to two websites for illegally selling Adderall, an attention deficit hyperactivity disorder (ADHD) treatment. Kubapharm.com and Premiumlightssupplier.com were both accused of selling amphetamine drugs marketed as the ADHD drug Adderall without a prescription, according to an FDA statement. The…

Benzinga

Oncternal Discontinues Enrollment In ONCT-216 Study For Soft Tissue Cancer

Oncternal Therapeutics Inc (NASDAQ:ONCT) will deprioritize further development of ONCT-216 to reallocate resources to zilovertamab, and its Phase 3 trial is expected to start in Q3 of 2022. The Company has discontinued enrollment in the Phase 1/2 study evaluating ONCT-216 in relapsed or refractory Ewing sarcoma, a type of tumor that forms in…

Benzinga

Coeptis Therapeutics Intends To Acquire Statera's TLR5 Agonist Platform

Coeptis Therapeutics Inc (OTC:COEP) has entered into a strategic agreement with Statera Biopharma Inc (NASDAQ:STAB) that gives Coeptis the right to acquire Statera'stoll-like receptor 5 (TLR5) agonist platform, including entolimod. Coeptis will agree to pay Statera Biopharma $6 million and revenue-based milestone payments to be defined in the definitive agreement. TLR5 is an innate immunity…

Benzinga

ProQR Therapeutics Pulls Plug On Inherited Retinal Disease Programs, Cuts 30% Workforce

ProQR Therapeutics N.V. (NASDAQ:PRQR) has decided to prioritize the development of genetic eye disease candidates and the Axiomer RNA base-editing technology platform. The Company will suspend the development of QR-1123 for autosomal dominant retinitis pigmentosa, QR-504a for Fuchs endothelial corneal dystrophy, and all other Inherited Retinal diseases (IRD)-related research activities. ProQR will implement…

Benzinga

Cannabis And Pancreatic Cancer: Botanical Drug Kills 100% Of Cancer Cells, Research On The Cell Model Reveals

Cannabotech (CNTC.TA), which is involved in the development of a botanical drug based on an extract of the Cyathus striatus fungus and a cannabinoid extract from the cannabis plant, reports that in experiments conducted on a cell model, the fungus extract eliminated 100% of pancreatic cancer cells relatively selectively and…

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