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The Latest Breaking News from FDA

BTAI: Final Countdown to April 5, 2022 PDUFA Date for BXCL501…

By David Bautz, PhD NASDAQ:BTAI READ THE FULL BTAI RESEARCH REPORT

Benzinga

Zosano Lays Off ~30% Of Its Workforce After FDA Rejection Of Migraine Drug Application

Zosano Pharma Corp (NASDAQ: ZSAN) is looking at strategic alternatives and

Benzinga

World Sleep Day: What an expert says about using melatonin to sleep

Melatonin is an over-the-counter sleep aid that’s loosely regulated by the FDA

The Independent UK

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Lexicon Announces Loan Facility Of $150M With Oxford Finance To Support Sotagliflozin Commercialization

Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) entered into a loan facility with Oxford Finance LLC for $150 million to support commercial preparations and the potential launch of sotagliflozin in heart failure. The loan facility consists of four tranches, each maturing in March 2027. An initial $25 million tranche was funded at closing. The second $25 million tranche…

Benzinga

B70m in fake cosmetic products seized

Police have seized about 70 million baht worth of fake cosmetic products bearing the names of 18 brands during a raid on a house in Bangkok’s Suan Luang district.

Bangkok Post

Like Pfizer, Moderna Seeks FDA Approval For Fourth COVID-19 Shot Or Second Booster Dose

Moderna Inc (NASDAQ: MRNA) has asked the FDA to authorize a

Benzinga

Moderna Seeks US Approval of Second Covid Booster

Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults. The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18…

Asharq Al-Awsat

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Carcinogenic chemical benzene found in hundreds of US personal care products

Independent lab found the chemical in more than a quarter of items it tested – sometimes at levels considered ‘life threatening’

The Guardian - US

Moderna asks FDA to authorize additional booster shot for all adults

The request is much broader than Pfizer's, which sought to authorize a second booster for people over 65.

Axios

OPNT: Data from OPNT003 Pharmacodynamic Trial in 2Q22…

By David Bautz, PhD NASDAQ:OPNT READ THE FULL OPNT RESEARCH REPORT

Benzinga

BLRX: 2021 Results

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

Benzinga

RVPH: 2021 Results

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

Benzinga

Why Are TC Biopharm Shares Trading Higher Today

The FDA has granted Orphan Drug designation to TC Biopharm Ltd's (NASDAQ:TCBP) lead product OmnImmune for use in Acute Myeloid Leukemia. After reviewing the Phase 1b/2a trial results in relapsed/refractory AML patients, the FDA approved the Company's application for Orphan Drug Status. "We look forward to the advancement of OmnImmune® in the Phase 2b/3…

Benzinga

Aquestive's AQST-109 Receives Fast Track Tag For Allergic Reactions

The FDA has granted Fast Track Designation to Aquestive Therapeutics Inc's (NASDAQ: AQST) AQST-109 for allergic reactions. AQST-109 is an orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.

Benzinga

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Benzinga

FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease

InflaRx N.V. (NASDAQ: IFRX) has

Tribune News Service

As abortion pills take off, some states move to curb them

In June, the U.S. Supreme Court is expected to weaken or topple its nearly 50-year-old abortion rights decision, Roe v. Wade, giving states wide latitude to restrict the procedure.

Benzinga

FDA Clears AbbVie's Rinvoq For Moderate To Severe Active Ulcerative Colitis

The FDA approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib) for adults patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from…

Benzinga

80 Biggest Movers From Yesterday

Gainers Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) shares gained 86.7% to close at $0.5150 on Wednesday after the company announced FDA clearance of its IND for SON-1010 for the treatment of advanced solid tumors.

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Los Angeles Times

Second COVID-19 booster shot does little to stop omicron, study finds

Israeli health care workers who were boosted with a fourth shot of COVID-19 vaccine at the height of the omicron wave were only marginally more protected against reinfection than their peers who had received three jabs of vaccine, researchers reported Wednesday.

Benzinga

FDA Lifts Clinical Hold On Aprea's Relapsed/Refractory Blood Cancer Studies

Aprea Therapeutics Inc (NASDAQ: APRE) can resume testing its eprenetapopt after a string of clinical holds on the therapy in August 2021. The Company plans to study the drug in new trials across various myeloid and lymphoid malignancies.

Benzinga

Medtronic's US Trial Of GI Genius Endoscopy Module Reduces Missed Colorectal Polyps By 50%

Medtronic plc (NYSE:MDT) announced final findings from a study that confirmed the effectiveness of the GI Genius intelligent endoscopy module. GI Genius uses AI to aid in detecting colorectal polyps during colonoscopy, potentially helping to prevent colorectal cancer (CRC). The study published in Gastroenterology found that the use of GI Genius in conjunction with…

Benzinga

FDA Removes Clinical Hold On AIM ImmunoTech's Mid-Stage Ampligen Trial In Pancreatic Cancer

The FDA has lifted the clinical hold on AIM ImmunoTech Inc's (NYSE:AIM) investigational new drug (IND) application for a Phase 2 study of Ampligen for locally advanced pancreatic cancer (AMP-270). The AMP-270 clinical trial's primary objective compares the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced…

Benzinga

Adagene Shares Pop After FDA Clears Phase 1b/2 Trial For ADG126/Keytruda Combo Therapy In Solid Tumors

The FDA has cleared Adagene Inc's (NASDAQ:ADAG) Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab). The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors. The ADG126-P001 trial is expected to dose the first patients soon. The trial is…

Benzinga

Sonnet Shares Surge As FDA Clears Its First Human Trial For Solid Tumor Candidate

The FDA has signed off Sonnet BioTherapeutics Holdings Inc's (NASDAQ:SONN) Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet's Fully Human Albumin Binding (FHAB) technology. Sonnet will initiate its First-in-Human Phase 1 trial in adult oncology patients in Q2 of 2022. The study will establish…

Benzinga

Iovance Receives FDA Allowance For IOV-4001 Study In Two Advanced Cancers

The FDA has signed off Iovance Biotherapeutics Inc's (NASDAQ:IOVA) Investigational New Drug Application (IND) first genetically modified TIL therapy, IOV-4001, for unresectable or metastatic melanoma and stage III or IV non-small-cell lung cancer (NSCLC). IOV-4001 leverages the gene-editing TALEN technology licensed from Cellectis SA (NASDAQ:CLLS). A clinical study of IOV-4001 in patients with metastatic melanoma…

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