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The Latest Breaking News from FDA

Stealth BioTherapeutics Shares Rally following FDA Orphan Drug Designation To Elamipretide For Duchenne muscular dystrophy (DMD)

Stealth BioTherapeutics Corp (NASDAQ: MITO) received Orphan Drug Designation to Elamipretide from the United States Food and Drug Administration (FDA) for the treatment of patients with Duchenne muscular dystrophy (DMD).

Benzinga

The Daily Biotech Pulse: Bristol Myers, BridgeBio Ink Oncology Pact, FDA Nod For Lava Therapeutics Blood Cancer Study And More

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

Benzinga

28 Stocks Moving in Thursday's Pre-Market Session

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) rose 89.7% to $0.1480 in pre-market trading after declining 9% on Wednesday. Allena Pharmaceuticals recently reported a $2.8 million registered direct offering.

Benzinga

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read the most diverse news in one place.

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

News briefs

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

Tribune News Service

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

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

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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

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

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

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

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

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

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

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Benzinga

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.

Daily Mirror

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'

Benzinga

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

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…

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Benzinga

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

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

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.

Benzinga

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

‘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

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

Fast-track drug approval process marked for limited changes

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