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The Latest Breaking News from FDA

Ardelyx Inc (NASDAQ: ARDX) shares are trading higher by 29.32% at $0.97 after the company reported it received an interim response from the OND, CDER and FDA for the company’s second level of appeal of the Complete Response Letter for XPHOZAH.

Benzinga

Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall

The FDA has informed that Axsome Therapeutics Inc (NASDAQ:AXSM) chemistry, manufacturing, and controls issues identified during the review of AXS-07 remain unresolved. The Company is seeking approval for AXS-07 for the acute treatment of migraine. Based on the time remaining in the review cycle, the Company expects to receive a Complete Response Letter…

Benzinga

Mid-Morning Market Update: Markets Open Lower; Dow Tumbles Over 300 Points

U.S. stocks opened lower this morning, with the Dow Jones dropping more than 300 points on Monday.

Benzinga

From analysis to the latest developments in health,
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Axsome Therapeutics' Good Fortune Reverses As Its Migraine Drug Hits A Hurdle

Axsome Therapeutics expects the Food and Drug Administration to reject its migraine treatment, leading AXSM stock to crumble on Monday.

Investors Business Daily

Why Axsome Therapeutics Stock Is Falling Today

Axsome Therapeutics Inc (NASDAQ: AXSM) shares are trading higher Monday after the company reported it was informed by the U.S.

Benzinga

Three Cabinet and two shadow ministers are reportedly facing sexual misconduct claims

They are among 56 MPs to be referred to a parliamentary conduct watchdog, The Sunday Times said

Evening Standard

Three Cabinet ministers reported for sexual misconduct, according to report

They are among 56 MPs to be referred to a parliamentary conduct watchdog, The Sunday Times said.

The Independent UK

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Rees-Mogg criticised for leaving ‘crass’ messages in empty Whitehall offices

The minister has left notes for civil servants working from home telling them he is ‘looking forward’ to seeing them back in the office.

The Independent UK

Looking for Value Stocks to Add to Your Portfolio? Here are 5 For Your List

Heightened inflationary pressure, deepening supply chain disruptions, and the possibility of aggressive interest rate hikes later this year have fostered a volatile stock market. Because these factors are not expected to abate anytime soon, we think investors looking to generate solid long-term returns could consider betting on the stocks of…

StockNews.com

60 Biggest Movers From Yesterday

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

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

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Benzinga

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

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.

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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

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…

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