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The Latest Breaking News from Food and Drug Administration

SQZ Biotechnologies Receives FDA Fast Track Designation for SQZ-PBMC-HPV for the Treatment of HPV16+ Tumors

SQZ Biotechnologies (NYSE: SQZ) received Fast Track Designation from he U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors. SQZ-PBMC-HPV-101 is currently being investigated in the Phase 1/2 clinical study.

Benzinga

McKinsey exec faces questions on opioid, FDA consulting work

A top McKinsey executive is answering congressional questions about his company’s consulting work for the Food and Drug Administration even as it advised opioid drugmakers on boosting sales

The Independent UK

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

Salon

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1st COVID treatment for kids under 12 gets FDA approval. What to know about Veklury

The Food and Drug Administration approved Veklury — also known as the drug remdesivir — as the first COVID-19 treatment for children younger than 12 on Monday, April 25.

McClatchy Washington Bureau

Why Quoin Pharmaceuticals Stock Is Trading Higher

Quoin Pharmaceuticals (NASDAQ: QNRX) shares are trading higher Monday after the company announced it received U.S. Food and Drug Administration clearance to initiate clinical testing for its Investigational New Drug application for QRX003.

Benzinga

FIR against online portal in Thane for selling abortion drugs

NAVI MUMBAI: A medical inspector attached to office of joint commissioner, Food and Drug Administration (FDA), Thane, on Saturday registered an FIR against Meesho, an online shopping portal, and M/s SS Traders, a medicine distributor based in Delhi, for selling abortion drugs online without doctor's prescriptions.

The Times of India

Why AlloVir Stock Is Surging Today

AlloVir Inc (NASDAQ: ALVR) shares are trading higher Wednesday after the company announced the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to its lead investigational multi-virus-specific T cell therapy, posoleucel.

Benzinga

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Checks and Balances: SEC publishes proposed climate disclosures rule

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

Ballotpedia

GlaxoSmithKline and AstraZeneca secure victories with US drug regulator

GlaxoSmithKline’s drug aimed at chronic kidney disease patients with anaemia and AstraZeneca’s lung cancer treatment have both moved a step closer to getting the green light

Evening Standard

COVID-19: First breathing test for detecting Coronavirus is authorized by FDA

The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use. Full story on Dynamite News:

Dynamite News

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

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

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

Commentary: Is a second booster for COVID-19 the right choice for you?

The Food and Drug Administration and the Centers for Disease Control and Prevention recently authorized a second booster shot of the Pfizer/BioNTech and Moderna COVID-19 vaccines for those age 50 and older. The recommendation follows a study out of Israel recently published in The New England Journal of Medicine.

Chicago Tribune

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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.

Benzinga

Why Biofrontera Stock Is Surging Today

Biofrontera Inc (NASDAQ: BFRI) shares are trading significantly higher Wednesday after the company announced it received U.S. Food and Drug Administration approval for its cGMP laboratory in Germany.

Benzinga

Why BriaCell Therapeutics Stock Is Surging Today

BriaCell Therapeutics Corp (NASDAQ: BCTX) shares are trading higher Wednesday after the company announced the U.S. Food and Drug Administration granted Fast Track status to Bria-IMT for the treatment of metastatic breast cancer.

Benzinga

Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

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Tribune News Service

Commentary: FDA shouldn’t approve ALS drug without more data

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

Chicago Sun-Times

FDA approves another COVID booster for 50 and up

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

Benzinga

The Daily Biotech Pulse: Sanofi-IGM Ink Antibody Drug Collaboration; NeoGenomics Sinks On CEO Departure, Q1 Warning; Decision Day For Akebia

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

The Independent UK

FDA reviews ALS drug after lobbying by patients, politicians

The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

Benzinga

Psyched: MindCure Shuts Down Operations, Novamind And MindMed Partner For Study

The psychedelics space was shaken up on the news that MindCure Health (OTC:MCURF) was shutting down operations. After a review process, the company’s board decided that MindCure’s business plan required more capital that it could gather under current market conditions, thus shutting down operations was considered the best move to preserve…

Asharq Al-Awsat

Moderna Seeks US Approval of Second Covid Booster

Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults. The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18…

The Independent UK

Moderna seeks FDA authorization for 4th dose of COVID shot

Drugmaker Moderna has asked the Food and Drug Administration to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults

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