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The Latest Breaking News from FDA

30 Stocks Moving In Thursday's Mid-Day Session

Gainers Swvl Holdings Corp. (NASDAQ: SWVL) shares gained 34.3% to $5.72. Alpha Tau Medical Ltd. (NASDAQ: DRTS) shares climbed 19.3% to $10.62.

Benzinga

NRx Pharmaceuticals Again Requests For FDA Breakthrough Therapy Status For COVID-19 Therapy

NRx Pharmaceuticals Inc (NASDAQ:NRXP) has filed a new Breakthrough Therapy designation request with the FDA for Zyesami focused on a subgroup of critical COVID-19 patients. The subgroup includes patients who were also treated with Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir) in addition to aviptadil or placebo. The request includes safety data on approximately 750 patients…

Benzinga

FDA Clears Moleculin's IND Application To Conduct Phase 1 Study Of WP1066 For Recurrent Malignant Glioma

Moleculin Biotech, Inc. (NASDAQ: MBRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application of the drug candidate WP1066 for Recurrent Malignant Glioma.

Benzinga

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FDA clears Moleculin's IND application to Conduct Phase 1 Study of WP1066 for Recurrent Malignant Glioma

Moleculin Biotech, Inc. (MBRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application of the drug candidate WP1066 for Recurrent Malignant Glioma The company plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label clinical study of oral…

Benzinga

The Daily Biotech Pulse: Ampio Falls On Knee Osteoarthritis Trial Update, AstraZeneca's COVID-19 Antibody Data, CureVac-GSK's Bivalent COVID-19 Vaccine Data

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

Benzinga

Ampio Pharma Shares Fall As FDA Rejects Proposed Change In Knee Osteoarthritis Trial

Ampio Pharmaceuticals Inc (NYSE: AMPE) received written responses from the FDA pursuant to a Type C meeting request regarding the AP-013 Phase 3 trial results.

Benzinga

FDA Warns Against Relying On Screening Tests For Prenatal Diagnosis

The U.S. FDA is warning that noninvasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when the fetus was healthy. FDA issues warning on possible false results from noninvasive prenatal screening tests. The agency noted that these tests, also known as…

Benzinga

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Finch Therapeutics Cuts 20% Workforce, Realigns Focus On C. Diff, Autism Programs

Finch Therapeutics Group Inc (NASDAQ:FNCH) announced the layoff of 20% of its staff in a regulatory filing. The cuts will impact 37 full-time employees. The FDA in March placed a clinical hold on the Phase 3 trial for CP101, a donor-derived microbiome drug for Clostridioides difficile, as well as a partial hold…

Benzinga

The Daily Biotech Pulse: Windtree Jumps On Istaroxime Data, Arcturus' COVID-19 Vaccine Trial Data, FDA Rejects Teva's Schizophrenia Med, Otonomy Aces Hearing Loss Study

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

Benzinga

FDA Rejects Teva - MedinCell's Schizophrenia Candidate

Teva Pharmaceutical Industries Ltd's (NYSE:TEVA) U.S. affiliate and MedinCell SA (OTC:MDCLF) have received FDA Complete Response Letter (CRL) regarding TV-46000/mdc-IRM for schizophrenia. The drug candidate is risperidone extended-release injectable suspension for subcutaneous use. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations. Related: Teva Reports…

Benzinga

Parents of kids under 5 still waiting for COVID shots

The demise of the federal transportation mask mandate was particularly jarring for many parents of children under five anxiously waiting for word on when COVID shots will become available to their kids.

Axios

Commentary: Confused about the second COVID booster? So are some of the experts

Vaccine resisters have accused the federal government of pushing COVID-19 shots without ensuring that the benefits outweigh the risks. But what about when one of the people raising questions about the latest round of jabs is Paul A. Offit, arguably the most prominent supporter of vaccines in the nation, a…

Los Angeles Times

Moderna says redesigned COVID-19 vaccine booster may work better against variants

Moderna’s updated COVID-19 booster shot shows even more efficiency against variants, the pharmaceutical company announced Tuesday, citing preliminary results from a trial.

Tribune News Service

EXCLUSIVE: Catalysts To Watch For In The Psychedelic Space

Any biotech investor knows how important catalysts are for the companies in the space. One FDA approval or denial can make or break the price of the stock. In the psychedelic space, catalysts could be even more important, as the industry as a whole is still in its infancy.

Benzinga

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Ballotpedia

Checks and Balances: SEC publishes proposed climate disclosures rule

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

Benzinga

Oaktree, Qatar Investment Inject $260M In BioXcel To Fund Commercialization Of Schizophrenia Med

BioXcel Therapeutics Inc (NASDAQ:BTAI) received strategic financing from Oaktree Capital Management and Qatar Investment Authority (QIA) for gross funding of $260 million. The Company will use the funding to support the commercial activities of Igalmi (dexmedetomidine) sublingual film indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.…

The Guardian - UK

Civil service unions condemn Rees-Mogg’s ‘vindictive’ back-to-office drive

Bosses of FDA and PCS criticise attempt by efficiency minister to name and shame departments with more remote workers

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting. The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. The application has also been…

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Benzinga

Needham Estimates PhaseBio Pharma's Bentracimab Market Opportunity Of Up To $1.5B

PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) remains on track to complete the bentracimab biologics license application (BLA) filing around mid-2022 for bleeding risks associated with using ticagrelor antiplatelet drug.

Benzinga

Despite Price Cut, HC Wainwright Keeps Buy Rating On TG Therapeutics - Read Why

TG Therapeutics Inc's (NASDAQ:TGTX) shares are plunging after new data showed that ublituximab /Ukoniq showed an elevated risk of death in the phase 3 Unity combo trial for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) HC Wainwright has slashed the price target from $68 to $19, with the Buy rating unchanged.…

Benzinga

Kaival Brands Expands Bidi Vapor Distribution

Kaival Brands Innovations Group Inc (NASDAQ:KAVL) has expanded its wholesaler and retailer distribution accounts for Bidi Vapor LLC, which are expected to reach 28,000 additional stores. "We anticipate the activation of approximately 3,900 new store locations over the next 45 days, including one new major retailer having already placed orders totaling more than $1.1 million," said…

Benzinga

FDA Investigating Reported Illnesses Tied To Lucky Charms Cereal

Scores of consumers weren’t feeling very lucky after eating General Mills’ (NYSE: GIS) Lucky Charms cereal, with multiple reports of illness occurring after having a bowl of the longtime breakfast staple.

Benzinga

Japan's Health Ministry Panel OKs Approval Of Novavax's COVID-19 Vaccine: Report

Japan's health ministry panel authorized a plan to approve Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine, which is set to be the fourth such vaccine to be approved in Japan. It will be available for first and second shots with an interval of three weeks. The Novavax product is a recombinant protein vaccine that uses…

Benzinga

Why Ocugen Shares Are Trading Higher Today

Ocugen Inc (NASDAQ:OCGN) and Bharat Biotech have amended their co-development, supply, and commercialization agreement to expand Ocugen's exclusive territory to include the commercialization of Covaxin in Mexico. This gives Ocugen Covaxin commercialization rights for all of North America. Covaxin can be an ideal vaccination option for Mexico at this pandemic stage. As a whole…

The Independent UK

Americans over 60 should get a second Covid vaccine booster, says White House official

Dr Ashish Jha said there was now ‘pretty compelling’ evidence that a second round of coronavirus booster vaccines would help protect older people

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