UNBELIEVABLE: 27 - The Untold Story

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 · Apr 14, 2022

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 · Apr 14, 2022

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 · Apr 14, 2022

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.

Benzinga · Apr 1, 2022

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.

Tribune News Service · Apr 1, 2022

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.

Chicago Sun-Times · Mar 29, 2022

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:

Benzinga · Mar 29, 2022

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

The Independent UK · Mar 24, 2022

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…

Benzinga · Mar 22, 2022

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…

Asharq Al-Awsat · Mar 18, 2022