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The Latest Breaking News from FDA

99 Biggest Movers From Yesterday

Gainers Armstrong Flooring, Inc. (NYSE: AFI) shares jumped 237% to settle at $0.49 on Wednesday after a 13D filing showed Esopus Creek Advisors LLC disclosed a 5.1% active stake in the company.

Benzinga · May 12, 2022

News briefs

This at-home COVID-19 test could give you a wrong result. Don’t use it, FDA warns

Tribune News Service · May 12, 2022

Government urged to stop ‘culture war’ against civil servants

Jacob Rees-Mogg accused of being ‘crass and condescending’ for leaving notes in offices.

The Independent UK · May 11, 2022

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This at-home COVID-19 test could give you a wrong result. Don’t use it, FDA warns

WASHINGTON — The Food and Drug Administration is warning to avoid using another at-home COVID-19 that could give a wrong result when used.

McClatchy Washington Bureau · May 11, 2022

Probe to check Covid deaths of vaccinated

Public Health Minister Anutin Charnvirakul has agreed to launch an investigation to find out why so many people have died from Covid-19 despite having had three vaccination shots.

Bangkok Post · May 11, 2022

US House panel sets hearing on baby formula shortage exacerbated by recall from Michigan plant

WASHINGTON — A U.S. House committee on Wednesday announced plans for a May 25 hearing on a national baby formula shortage fueled in part by a February recall by the manufacturer Abbot for products made at its Michigan plant.

Tribune News Service · May 11, 2022

Salarius Pharmaceuticals Successfully Completes pre-IND Meeting with FDA for SP-3164

Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) successfully completed the pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for SP-3164 in hematological cancers and solid tumors.

Benzinga · May 11, 2022

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COVID-19 Symptoms Rebound After Pfizer's COVID-19 Therapy, What Could Be The Reason?

Some patients have reported that COVID-19 symptoms recurred after completing treatment and experiencing improvement after Pfizer Inc's (NYSE: PFE) COVID-19 oral antiviral treatment Paxlovid.

Benzinga · May 11, 2022

Almost 400M COVID-19 Vaccine Doses Lost Due To Emergent's Baltimore Plant Fiasco

According to a recent report from the US House select subcommittee on the coronavirus crisis, Emergent Biosolutions Inc (NYSE:EBS) might have destroyed nearly 400 million doses of COVID-19 vaccines after failing to meet quality standards. Initially, 75 million - 85 million doses of drug substance were said to be destroyed after contamination. "Despite major…

Benzinga · May 11, 2022

What Does HC Wainwright Have To Say On Avadel's Narcolepsy Candidate's Potential Approval?

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) reported 1Q results and provided updated color on the U.S. marketing application for FT218.

Benzinga · May 11, 2022

What's The FDA's Regulatory Impact On The Cannabis Industry? Find Out In This Webinar

What's the Food and Drug Administration's impact on the cannabis industry?

Benzinga · May 11, 2022

52 Stocks Moving In Wednesday's Mid-Day Session

Gainers Trecora Resources (NYSE: TREC) shares jumped 26.6% to $9.56 as the company agreed to be acquired by an affiliate of Balmoral Funds at $9.81 per share in cash or an enterprise value of $247 million.

Benzinga · May 11, 2022

Common dog toy cleaning mistake that could be making you and your pet sick

Veterinarian Dr Lynn Happel is urging owners to wash their dog's toys at least once a month to avoid them from picking up an illness from 'respiratory corona virus or a micro-plasma bacteria'

Daily Mirror · May 11, 2022

FDA Accepts IND for Cue Biopharma's CUE-102 in the treatment of Wilms' Tumor 1 (WT1)

Cue Biopharma, Inc. (NASDAQ: CUE) received the U.S. Food and Drug Administration (FDA) acceptance of the Investigational New Drug (IND) application for the evaluation of CUE-102 in the treatment of Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.

Benzinga · May 11, 2022

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Benzinga · May 11, 2022

Why Are Inovio Shares Plummeting Today

Joseph Kim, the longtime CEO of Inovio Pharmaceuticals Inc (NASDAQ:INO), is stepping down to make room for Jacqueline Shea, who first joined Inovio as COO in 2019. Shea will be overseeing a change in direction as Inovio, a laggard in the COVID-19 vaccine race, has closed a Phase 3 trial in favor of a…

Benzinga · May 11, 2022

The Daily Biotech Pulse: Veru Shares Up On COVID Candidate Update, FDA Approves Lilly's COVID Treatment, Latest On Sanofi-AstraZeneca RSV Vaccine

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

Benzinga · May 11, 2022

FDA Clears Regulus Therapeutics' IND for RGLS8429 In Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Benzinga · May 11, 2022

FDA Approves Lilly and Incyte's OLUMIANT (baricitinib) for Hospitalized Patients with COVID-19

The U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized patients.

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Benzinga · May 11, 2022

Why Veru Shares Are Soaring Today Premarket

In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients. The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for…

France 24 · May 11, 2022

‘Hurt, angry, anxious, scared’: Converging crises lead to US baby formula shortage

Along with much of the globe, US consumers are reeling from a cost of living and supply-chain crisis. One example is a shortage of baby formula caused by a constellation of factors, from rampant inflation to a massive recall over safety concerns.

Benzinga · May 11, 2022

Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19

The FDA approved Eli Lilly And Co's (NYSE:LLY) Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. The FDA first issued an emergency use authorization (EUA) for Olumiant combined with remdesivir to treat…

Axios · May 11, 2022

Fast-track drug approval process marked for limited changes

Tribune News Service · May 11, 2022

Can a monthly injection be the key to curbing addiction? These experts say yes

OAKLAND, Calif. — Dr. Andrew Herring has a clear goal walking into every appointment with patients seeking medication to treat an opioid use disorder: persuade them to get an injection of extended-release buprenorphine.

Axios · May 10, 2022

FDA says it is "doing everything in our power" to improve baby formula supply

The shortage has intensified in recent weeks due to supply chain issues and a devastating recall.

Benzinga · May 10, 2022

FDA Extends Review Of Amicus Therapeutics' AT-GAA For The Treatment Of Pompe Disease By Three Months

The U.S.

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