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The Latest Breaking News from FDA

Gainers Cyngn Inc. (NASDAQ: CYN) shares jumped 96.3% to close at $2.12 on Thursday after the company announced the official launch of DriveMod Kit, a turnkey autonomous vehicle solution.

Benzinga

Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Glabellar Lines

Revance Therapeutics, Inc. (NASDAQ: RVNC) announced acceptance of Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) of its drug candidate DaxibotulinumtoxinA for Injection for the treatment of patients with moderate to severe glabellar lines.

Benzinga

FDA Puts Blood Cancer Nods Under Scrutiny On Substantial Toxicity Profile Of PI3K Drugs

The FDA aims to put the PI3K inhibitor drug class under a more stringent regulatory scope as the inhibitor has demonstrated substantial toxicity.

Benzinga

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Mid-Afternoon Market Update: Nasdaq Down 200 Points; United Airlines Shares Jump

U.S. stocks turned lower toward the end of trading, with the Nasdaq dropping 200 points on Thursday.

Benzinga

5 Beaten-Down Biotech Stocks Cathie Wood Loves

Renowned investor Cathie Wood of ARK Invest is known for her eye for stocks with enormous upside potential. Despite recent macro headwinds, the biotech industry is expected to grow tremendously in 2022, supported by strong demand for healthcare and medical products and increasing investments in R&D. Given these factors, Wall…

StockNews.com

Mid-Day Market Update: Nasdaq Turns Negative; US Weekly Jobless Claims Edge Lower

U.S. stocks pared gains midway through trading, with the Nasdaq Composite dropping around 50 points on Thursday.

Benzinga

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

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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

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

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

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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…

Axios

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.

Los Angeles Times

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…

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Tribune News Service

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.

Benzinga

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.

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…

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.

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