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The Latest Breaking News from FDA

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

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

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

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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.

Benzinga

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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…

Benzinga

‘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.

France 24

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…

Benzinga

Fast-track drug approval process marked for limited changes

Axios

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.

Tribune News Service

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.

Axios

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

The U.S.

Benzinga

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Benzinga

LPCN: First Quarter 2022 Financial and Operational Results

By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT

Benzinga

Fake Cannabis Vapes: How To Tell If Your Weed Vape Cartridge Is Safe Or Counterfeit?

By WeedMaps News' Tyler Koslow, provided exclusively to Benzinga Cannabis.

Benzinga

PreMarket Prep Stock Of The Day: Good News From Aurinia Pharmaceuticals In A Down Week

Rarely mentioned in the recent chaos in the markets is the biotech sector. With a heavy emphasis in 2020 and 2021 on finding cures and treatments for COVID-19, major drug approvals from the FDA have been few and far between this year.

The Independent UK

Parents hunting for baby formula as shortage spans US

Parents across the U.S. are scrambling to find baby formula because of supply disruptions and a massive safety recall by manufacturer Abbott

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Benzinga

Robust Uptake Of Antipsychotic Drug Boosts Intra-Cellular's Q1 Earnings

Intra-Cellular Therapies Inc's (NASDAQ:ITCI) Q1 revenues reached $35.0 million, compared to $15.9 million a year ago, beating the consensus of $33.65 million. Net product revenues of Caplyta were $34.8 million, compared to $15.6 million in Q1 FY21. The company reported an EPS loss of $(0.78), beating the consensus of $(0.92) and higher…

Benzinga

Why This Analyst Has 'Little Conviction' On CRISPR's Upcoming Trial Data

RBC Capital Markets says it remains on the sidelines given commercial uptake for CRISPR Therapeutics' (NASDAQ: CRSP) sickle cell disease (SCD)/beta-thalassemia (BT) capped by preconditioning and has little conviction in BCMA/CD70 data within weeks. The analysts lowered its price target to $85 from $95 to reflect higher Opex, with a Sector Perform rating. As recently…

Chicago Tribune

Parents struggle with baby formula shortage. ‘It’s kind of scary’

For the first months of her life, Ashley Strom’s daughter seemed uncomfortable much of the time — vomiting frequently, squirming with acid reflux and sleeping poorly.

Benzinga

Amid Baby Formula Shortage, Retailers Put Cap On Purchases: Report

The U.S. faced a nationwide shortage of the most popular baby formula brands in the week starting April 24, according to the latest figures from Datasembly, which tracks out-of-stock messages on retailers' websites and apps. An average rate is less than 10%. Reasons For The Shortage: Supply chain issues caused by the COVID-19…

Benzinga

Ecstasy Research Trial Completes Enrollment, Moves Closer To Approval To Treat PTSD

The non-profit Multidisciplinary Association for Psychedelics Studies (MAPS) and its subsidiary MAPS Public Benefit Corporation finished the enrollment stage for the second Phase 3 clinical trial on MDMA (MAPP2).

Tribune News Service

400 million COVID-19 vaccine doses dumped by Baltimore plant, congressional report finds

BALTIMORE — The Maryland-based vaccine maker Emergent BioSolutions was forced to destroy nearly 400 million doses of COVID-19 vaccine because of potential contamination at its East Baltimore plant, far more than previously known.

Reason

The U.S. Baby Formula Shortage Is the FDA's Fault

Plus: Trusting the science is now an explicitly partisan issue, stocks are still plummeting, and more...

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