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The Latest Breaking News from FDA

Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids

Reuters reported that Moderna Inc (NASDAQ:MRNA) had made required submissions to the FDA for emergency use authorization of its COVID-19 vaccine in adolescents and children. An advisory panel of experts to the U.S. drug regulator will meet in June to review the request. Related: FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For…

Benzinga

Biden to speak to baby formula manufacturers about shortage

President Joe Biden plans to speak on Thursday with baby formula manufacturers and retailers about the plight of families struggling to find formula due to supply chain disruptions and a safety recall

The Independent UK

Protara Therapeutics Shares Retrospective Analysis Of OK-432 In Rare Lymphatic Malformations

Protara Therapeutics Inc (NASDAQ:TARA) announced the results of a retrospective analysis of OK-432, the originator compound for TARA-002, its investigational therapy in development for lymphatic malformations (LMs), rare, congenital malformations of lymphatic vessels. The results from the analysis showed that OK-432 was clinically successful and generally well-tolerated in the treatment of both macrocystic…

Benzinga

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Rockwell Medical Submits Additional Data For IND Application For Iron Deficiency Candidate

Rockwell Medical Inc (NASDAQ:RMTI) has provided the FDA with the supplemental data requested by the agency in December 2021 for its pending Investigational New Drug (IND) application of Ferric Pyrophosphate Citrate (FPC) for iron deficiency. The IND supports the proposed Phase 2 trial of FPC for treating iron deficiency anemia and maintaining hemoglobin…

Benzinga

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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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

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

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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?

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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…

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.

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