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Published on 08:40 GMT

US FDA accepts Novo Nordisk's NDA submission for oral semaglutide 25 mg for treatment of obesity

Novo Nordisk, a leading global healthcare company, announced that the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic …

Source: Pharmabiz.com - Neutral
Published on 12:06 GMT

FDA accepts Novo Nordisk’s NDA submission for weight management therapy

The US Food and Drug Administration (FDA) has accepted Novo Nordisk’s new drug application (NDA) submission for the 25 mg oral formulation of Wegovy (semaglutide) intended for chronic weight management in adult obese or overweight patients with one or more …

Source: Pharmaceutical Technology - Neutral
Published on 16:34 GMT

FDA decision on oral Wegovy coming in Q4

Novo Nordisk has pulled ahead in the race to bring the first oral GLP-1 for obesity to market. The company announced Friday that the FDA has accepted its New Drug Application (NDA) submission for a once-a-day 25mg pill form of Wegovy (semiglutide) for …

Source: pharmaphorum - Neutral
Published on 11:35 GMT

Alterity Therapeutics Granted U.S. FDA Fast Track Designation for ATH434 to Treat Multiple System Atrophy

– Fast Track Designation highlights potential of ATH434 to address high unmet need for individuals with MSA – MELBOURNE, Australia and SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the …

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Published on 11:50 GMT

FDA Grants Fast Track Designation to OKYO Pharma’s Urcosimod for Neuropathic Corneal Pain

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OKYO Pharma for its investigational candidate urcosimod, intended for the treatment of neuropathic corneal pain (NCP). NCP is a rare and severely painful condition affecting …

Source: Ophthalmology Breaking News - Neutral
Published on 11:53 GMT

ALDX SECURITIES ALERT: Lose Money on Aldeyra Therapeutics, Inc.? Contact BFA Law about Securities Investigation (NASDAQ:...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) for potential violations of the federal securities laws. If you invested in …

Distribution channels: Consumer Goods, Law ...
Published on 11:51 GMT

European Shares Mostly Higher As Investors Look Ahead To Fed, BoE Meetings

European shares traded mostly higher on Monday as investors awaited new updates on the tariff front and looked ahead to interest rate decisions from the Federal Reserve and the Bank of England, due later this week. U.S. President Donald Trump on Sunday …

Source: RTTNews - Neutral
Published on 13:53 GMT

BioCryst Pharma Stock Soars 10% Pre-Market On Upbeat Q1 Earnings, Improved Full Year Guidance: Retail’s Pleased

BioCryst now expects global net Orladeyo revenue to be between $580 million and $600 million for the full year, up from its previous guidance of between $535 million and $550 million. Shares of BioCryst Pharmaceuticals, Inc. (BCRX) soared 10% in pre-market …

Source: myMotherLode - Pending
Published on 13:48 GMT

Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill

The FDA on Friday accepted Novo Nordisk’s New Drug Application for an oral formulation of its widely popular obesity drug Wegovy for chronic weight management, bringing the Danish drugmaker one step closer to winning the first regulatory approval for a GLP …

Source: BioSpace - Pending
Published on 12:58 GMT

EXCLUSIVE: Lantern Advances Breast Cancer Drug Candidate With FDA Clearance For Early-Stage Trial

The U.S. Food and Drug Administration (FDA) on Monday cleared Lantern Pharma Inc.’s LTRN Investigational New Drug Application (IND) for a Phase 1b/2 trial for LP-184 in triple-negative breast cancer (TNBC). The dual approach in the clinical trial is …

Source: Benzinga - Neutral
Published on 12:06 GMT

Chinese regulator grants priority review for InnoCare’s solid tumour treatment

China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma’s zurletrectinib (ICP-723) for advanced solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK) fusion …

Source: Pharmaceutical Technology - Neutral
Published on 17:30 GMT

Senores Pharmaceuticals acquires ANDA for Topiramate tablets from Wockhardt

Senores Pharmaceuticals Limited (SPL), through its wholly-owned U.S. subsidiary Senores Pharmaceuticals, Inc. (SPI), has entered into an agreement to acquire the USFDA-approved Abbreviated New Drug Application (ANDA) for Topiramate Hydrochloride tablets ( …

Source: Business Upturn - Pending
Published on 13:51 GMT

Long-Term Shareholders Have Rights – If You Hold Akero Therapeutics, Inc. (NASDAQ: AKRO); Integra Lifesciences Holdings ...

PHILADELPHIA, May 05, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ: AKRO): Grabar Law Office is investigating whether certain officers and directors of Akero breached their fiduciary duties owed to the company. If you have held Akero …

Distribution channels: Business & Economy, Law ...
Published on 14:12 GMT

INVESTOR ALERT: Pomerantz Law Firm Announces the Filing of a Class Action Against Sana Biotechnology, Inc. and Certain ...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Sana Biotechnology, Inc. (“Sana” or the “Company”) (NASDAQ: SANA) and certain officers. The class action, filed in the United States …

Distribution channels: Consumer Goods, Law ...
Published on May 1, 2025

FDA Filing Fee Waiver for New Drug Application of NRX-100 for Suicidal Depression

NRx Pharmaceuticals announced the grant of a filing fee waiver by the US Food and Drug Administration (FDA) to exempt NRx from a $4.3 million fee to file its New Drug Application for preservative-free ketamine (NRX-100). NRX-100 is a preservative-free …

Source: Psychiatric Times - New Jersey - Pending
Published on 06:30 GMT

Inventiva obtient la deuxième tranche de 116 millions d'euros de son financement structuré d'un montant maximum de 348 ...

Le financement intervient à la suite de la fin du recrutement de l’étude clinique de Phase 3 NATiV3 évaluant lanifibranor chez les patients atteints de MASH et à la suite de l’atteinte d’autres conditions préalables. Daix (France), New York City (New York …

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Published on 06:30 GMT

Inventiva secures the €116 million second tranche of its structured financing of up to €348 million

Financing follows completion of enrollment of Phase 3 NATiV3 study evaluating lanifibranor in MASH and satisfaction of other specified conditions. Daix (France), New York City (New York, United States), May 5, 2025 – Inventiva (Euronext Paris and Nasdaq: …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on 13:34 GMT

Nrx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application For NRX-100, Its Proprietary, Preservative Free ...

(MENAFN- PR Newswire) NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering …

Source: MENAFN - Indeterminate
Published on 04:03 GMT

Stocktwits Spotlight: NRx, CVS, ReShape Lead Weekly Jump In Health Care Stock Chatter

Favorable regulatory moves for a new drug application, blowout earnings and promising preclinical data triggered a flurry of discussions on Stocktwits for these tickers for the week ended May 2, 2025. NRx Pharmaceuticals Inc. (NRXP) (+900% Weekly Message …

Source: myMotherLode - Pending

07 days 10:02:44

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Published on May 5, 2025 - 06:14 GMT

Global Extended Release Drugs Market Set to Reach CAGR of 11% through 2032 | FMI

Extended Release Drugs Market sees rising demand due to improved patient compliance, steady dosing, and reduced side effects. NEWARK, DE, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- The global extended release drugs market is witnessing …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 14:00 GMT

Atticus Pharma Announces Upcoming Late-Breaking Presentation of Collaborative Research at the 82nd Annual SID 2025

GREENVILLE, SC, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Atticus Pharma Inc, a therapeutics company focused on immunodermatology and associated conditions, today announced the presentation of pre-clinical results in a novel murine model …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...

Published on May 5, 2025 - 10:41 GMT

Quintex Pharma and GL Rapha Announce Formation of Quinn Biopharma Ltd to Advance Pharmaceutical Manufacturing in Africa

SEOUL, SOUTH KOREA, May 5, 2025 /⁨EINPresswire.com⁩/ -- Quintex Pharma Ltd of Ghana and GL Rapha Co., Ltd of Korea have officially announced the formation of Quinn Biopharma Ltd, a groundbreaking joint venture that aims to transform pharmaceutical …

Distribution channels: Chemical Industry, Companies ...
Published on May 5, 2025 - 12:00 GMT

SignPath Pharma Announces ASCO 2025 Abstract Featuring LipoCurc for Glioblastoma

Phase I/II study of LipoCurc™ in glioblastoma accepted for poster presentation at ASCO 2025, in collaboration with Johns Hopkins. SANDY, UT, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- SignPath Pharma, Inc., a Delaware-incorporated …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...

Published on May 5, 2025 - 15:08 GMT

Butyric Acid Market Size Worth USD 634.55 Million by 2034 Driven by Rising Demand Across Animal Feed and Pharmaceutical ...

Ottawa, May 05, 2025 (GLOBE NEWSWIRE) -- The global butyric acid market size has been calculated at USD 422.13 million in 2025 and is estimated to rise from USD 440.28 million in 2026 to USD 634.55 million by 2034. The large application of butyric acid in …

Distribution channels: Consumer Goods, Science ...
Published on May 5, 2025 - 15:12 GMT

INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Actinium Pharmaceuticals, Inc. ...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Actinium Pharmaceuticals, Inc. (“Actinium” or the “Company”) (NYSE: ATNM). Such investors are advised to contact Danielle Peyton at …

Distribution channels: Consumer Goods, Law ...
Published on May 5, 2025 - 12:00 GMT

ARS Pharmaceuticals Announces Conference Call and Webcast for its First Quarter 2025 Financial Results

SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, …

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Published on May 5, 2025 - 11:00 GMT

ANI Pharmaceuticals Announces Presentation of Preclinical Data on the Use of Purified Cortrophin® Gel in an Experimental ...

Demonstrated Dose Dependent Effect in EAU Presented in a podium presentation at The Association for Research in Vision and Ophthalmology (ARVO) 2025 annual meeting PRINCETON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...

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Published on May 5, 2025 - 17:48 GMT

Beyond Dental Care Named Best Family Dentist in North Glendale, AZ, Offering Cosmetic Dentistry and Emergency Services

Beyond Dental Care provides trusted preventive, cosmetic, and emergency dental services to teens, adults, and seniors in North Glendale, AZ. GLENDALE, AZ, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Beyond Dental Care, proudly serving North …

Distribution channels: Beauty & Hair Care, Emergency Services ...
Published on May 5, 2025 - 17:40 GMT

Trusted Tooth Replacement Specialist in Scottsdale, AZ Now Offering Advanced All-on-4® Dental Implants

Scottsdale's leading dental implant provider enhances smile restoration options with cutting-edge All-on-4® solutions and personalized restorative care. SCOTTSDALE, AZ, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- For those searching …

Distribution channels: Beauty & Hair Care, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 17:06 GMT

Consilium Staffing Introduces Concierge Departments to Enhance Provider Experience

A leader in locum tenens, Consilium Staffing announces the creation of two specialized departments: The Travel Concierge and The Payment Concierge. IRVING, TX, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- A leader in locum tenens, Consilium …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 16:34 GMT

Aperio Promotes Stacey King to VP of Data Management

Stacey has been a key part of Aperio’s leadership team since 2016, building a dedicated Data Management department from the ground up. DURHAM, NC, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Aperio Clinical Outcomes, a leading provider of …

Distribution channels: Banking, Finance & Investment Industry, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 16:31 GMT

AlviArmani Patients Seeing Faster Results with PRP-Enhanced Hair Restoration Procedures

AlviArmani Patients Seeing Faster Results with PRP-Enhanced Hair Restoration Procedures BEVERLY HILLS, CA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- AlviArmani, a global leader in advanced hair restoration, is pleased to share promising …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on May 5, 2025 - 16:23 GMT

Sisters of the Valley Announce a Very Special Sale in Honor of Mother’s Day

35% off in All Sister Stores as a Salute to Mothers and Caregivers MERCED, CA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- In a tribute to mothers and caregivers around the world, the Sisters of the Valley are offering a rare 35% discount across …

Distribution channels: Agriculture, Farming & Forestry Industry, Culture, Society & Lifestyle ...
Published on May 5, 2025 - 16:23 GMT

The Silent Struggle: Understanding the Mental Health Effects of Bullying

Join Stand for the Silent in Their Mission to Support Affected Students and Foster Resilience. OKLAHOMA CITY, OKLA. , OK, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- May is National Mental Health Awareness Month, making it a great time to …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 5, 2025 - 16:22 GMT

SABER College Now Enrolling for May 12 Start of Professional Nursing Program Amidst Growing Demand for RNs

Career-ready training, small class sizes, and clinical experience prepare students to enter the nursing profession with confidence and purpose. MIAMI, FL, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- As the demand for Registered Nurses grows …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on May 5, 2025 - 16:19 GMT

Four Galen College of Nursing Campuses Named 'Opportunity Colleges' by Prestigious Carnegie Foundation

Galen College of Nursing has earned a prestigious new honor, being named an ‘Opportunity College’ by the Carnegie Foundation for the Advancement of Teaching. LOUISVILLE, KY, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Galen College of …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 16:00 GMT

From Fear to Love Tour Brings Family-Centered Emotional Healing to Kansas City

KANSAS CITY, KS, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Kansas City will welcome nationally recognized parenting and trauma expert Bryan Post on May 15, 2025, as part of his ongoing From Fear to Love World Tour. This in-person event …

Distribution channels: Book Publishing Industry, Culture, Society & Lifestyle ...
Published on May 5, 2025 - 15:57 GMT

Ana Launches the World’s First Autonomous AI/ML Engineer

NEW YORK, NY, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- OpenAna, the innovation-driven AI company, today announced the launch of Ana, the world’s first Autonomous AI/ML Engineer, capable of independently building machine learning …

Distribution channels: Banking, Finance & Investment Industry, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 15:53 GMT

Navrogen Announces Publication on the CA125-Refractory NAV-006 Ab Treatment of Immunosuppressed Follicular Lymphoma

Navrogen Inc Announces Publication on the CA125-Refractory NAV-006 Antibody for the Treatment of Immunosuppressed Follicular Lymphoma CHEYNEY, PA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Cheyney, PA, May, 5 2025 - Navrogen, Inc., a …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 15:30 GMT

Macedon Technologies named 2025 North American Appian Partner Innovation Award winner for No Surprises Act solution

Macedon’s award-winning No Surprises Act (NSA) solution has leveraged AI Automation to automate 85% of the No Surprises Act's claim processing RESTON, VA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Macedon, a Premier Appian Partner …

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Published on May 5, 2025 - 15:17 GMT

StopOCD.com Launches Groundbreaking Online OCD Treatment Program

Making Expert OCD Therapy More Accessible Through a Digital-First, Evidence-Based Approach CA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Millions of people with Obsessive-Compulsive Disorder (OCD) struggle to find specialized help—often …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 15:02 GMT

GenCare Lifestyle Launches "Through Their Eyes", Offering Insight into Grandparents from their Grandchildren

GenCare Lifestyle Senior Living launches Through Their Eyes — and celebrates grandparents with Mother's Day and Father's Day events SEATTLE, WA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- GenCare Lifestyle Senior Living, a …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 5, 2025 - 15:00 GMT

DSN Software Acquires OMS Billing Solutions, Strengthening Leading Practice Management Offering for Specialty Dental

Combining Expertise to Bridge the Gap Between Practice Management and Revenue Cycle Services TULSA, OK, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- DSN Software, the leading practice management solution for oral surgeons, has announced its …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on May 5, 2025 - 15:00 GMT

Medicaid Patients Using Telepsychiatry Associated With Reduced Hospital Admissions

Montana Study Identifies 38% Lower Hospitalization Rates and Similar Total Healthcare Costs Among Remote Care Recipients BILLINGS, MT, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Medicaid patients with psychiatric disorders who received …

Distribution channels: Banking, Finance & Investment Industry, Emergency Services ...
Published on May 5, 2025 - 15:00 GMT

New Grant Fuels Major Initiative to Support Rare Disease Caregivers Through Genetic Testing Access

This grant helps CAN reinforce its commitment to supporting caregivers—by working to remove barriers to diagnosis & care for families affected by rare diseases. WASHINGTON, DC, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Caregiver …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on May 5, 2025 - 14:50 GMT

WPS Named VETS Indexes 4 Star Employer

Company earns recognition for third consecutive year MADISON, WI, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- WPS, a health solutions company, has been recognized as a VETS Indexes 4 Star Employer in the 2025 VETS Indexes Employer Awards …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 14:29 GMT

New Analysis Highlights Urgent Need for Medicaid Reform and Equity-Focused Healthcare Strategies

Dr. Jonathan Kenigson explores US Medicaid for readers in London and surrounding areas who are following US healthcare equity debates. SOUTHAMPTON, UNITED KINGDOM, May 5, 2025 /⁨EINPresswire.com⁩/ -- A groundbreaking new article, American Medical …

Distribution channels: Healthcare & Pharmaceuticals Industry, Human Rights ...