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The Latest Breaking News from FDA

The FDA just approved a very quick, very accurate COVID breathalyzer test

Good riddance, brain-poking swabs.

Mic

New state laws restrict abortion pills

Doctors abilities to consult patients on abortions is being further restricted by new legislation

Salon

When mice vape, flavor matters

Curiously, different JUUL flavors seemed to have different (negative) effects on mice in a novel e-cigarette study

Salon

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

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

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

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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

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

Protagonist Therapeutics Dives As Its Drama Continues With A New FDA Concern

Protagonist says the FDA plans to revoke its breakthrough designation for a blood cancer drug, and PTGX stock collapsed Thursday.

Investors Business Daily

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

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news in one place.

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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…

The Conversation

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.

Benzinga

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

Protagonist Therapeutics Inc (NASDAQ: PTGX)

Benzinga

Amneal Scores Second US Biosimilars Approval With Alymsys In Oncology

The

Get all your
news in one place.

100’s of premium titles.
One news app.

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.

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…

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