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Published on May 28, 2025

Mitsubishi Tanabe Pharma America Announces U.S. FDA Acceptance of New Drug Application Resubmission for Investigational ...

JERSEY CITY, N.J., May 28, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24 …

Source: WISC Channel 3000 - Wisconsin - Neutral
Published on May 28, 2025

U.S. FDA Accepts New Drug Application Under Priority Review for sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell ...

Regulatory submission is based on positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC). Investigational agent sevabertinib (BAY 2927088) is an oral, small molecule, tyrosine …

Source: The AI Journal - Pending
Published on 13:57 GMT

FDA approves hydrocortisone oral solution for children 5 years, older with adrenocortical insufficiency

On May 28, 2025, the FDA approved Eton Pharmaceuticals' new drug application (NDA) for hydrocortisone oral solution (Khindivi) as a replacement therapy for pediatric patients aged 5 years or older with adrenocortical insufficiency, according to a press …

Source: Contemporary Pediatrics - Pending
Published on 13:34 GMT

FDA approves Eton’s application for hydrocortisone oral solution

Eton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval as a replacement therapy for children aged five years and above with adrenocortical insufficiency …

Source: Pharmaceutical Technology - Neutral
Published on May 28, 2025

Eton Pharmaceuticals Announces U.S. FDA Approval for KHINDIVI™ (hydrocortisone) Oral Solution

• KHINDIVI is the first and only FDA-approved hydrocortisone oral solution • Commercial launch expected the week of June 2nd • Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK …

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Published on 11:00 GMT

Axsome Therapeutics to Participate in Upcoming Investor Conferences

NEW YORK, May 29, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it will participate in three upcoming …

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Published on 14:02 GMT

Ocular Therapeutix to Complete Enrollment in SOL-R Trial for Axpaxli in Wet AMD

Ocular Therapeutix has announced that enrollment will close this week for its SOL-R registrational trial evaluating Axpaxli (OTX-TKI) in patients with wet age-related macular degeneration (AMD). The SOL-R trial is considered the largest retinal tyrosine …

Source: Ophthalmology Breaking News - Neutral
Published on 15:52 GMT

Dermatology Times May 2025 Recap

Clearances, Approvals, Updates, and Recommendations FDA Approves Sun Pharma's New LED BLU-U Device for AK Sun Pharma's innovative BLU-U device gains FDA approval, revolutionizing actinic keratosis treatment with advanced blue light therapy. FDA …

Source: Dermatology Times - Neutral
Published on 11:37 GMT

Biogen and City Therapeutics to develop RNAi therapies in deal worth over $1bn

Biogen and City Therapeutics have announced a partnership worth over $1bn to develop new RNAi therapies. The collaboration will initially centre on a single target that “mediates key central nervous system diseases” and will use tissue enhanced delivery …

Source: PMLiVE - Neutral
Published on 07:26 GMT

Affordable innovation: Akhil Ravi

Aurigene Pharmaceutical Services is a rising star in the contract development and manufacturing organization (CDMO) market, known for its innovative approach and high-quality services that differentiate it from its competitors. “We have one of the longest …

Source: The CEO Magazine - Neutral
Published on 14:38 GMT

FDA Approves Khindivi, First Oral Solution of Hydrocortisone, for Pediatric Patients

This is an ongoing story. The FDA approved the new drug application for hydrocortisone oral solution (Khindivi; Eton Pharmaceuticals) as a replacement therapy in pediatric patients with adrenocortical insufficiency who are 5 years of age and older. This …

Source: Pharmacy Times - Neutral
Published on 12:30 GMT

Clinical Trial Supply & Logistics Market Surges as Pharma Expands Global Trials | CAGR - 7.63% | DataM Intelligence

In-depth analysis of the clinical trial supply & logistics market, with insights into growth drivers, regions, companies, and recent U.S. & Japan news. AUSTIN, TX, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Clinical Trial Supply & …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 27, 2025

UroGen Pharma Ltd. (URGN) Shares Crash Again Amid FDA’s ODAC Vote Against UGN-102, Company Facing Investor Scrutiny – ...

SAN FRANCISCO, May 27, 2025 (GLOBE NEWSWIRE) -- On May 21, 2025, investors in UroGen Pharma Ltd. (NASDAQ: URGN) saw the price of their shares crash 44% after the company announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted against the …

Distribution channels: Consumer Goods, Law ...
Published on 04:11 GMT

Guess which ASX 200 stock is jumping 10% on big news

This stock is catching the eye with a strong gain on Thursday. But why? Posted by James Mickleboro has been a Motley Fool contributor since late 2015. After studying economics at university back home in the United Kingdom, James came to live in Australia …

Source: The Motley Fool Australia - Neutral
Published on 04:11 GMT

Why Champion Iron, Clarity Pharmaceuticals, St Barbara, and Woodside shares are charging higher today

These shares are having a good session today. But why are investors buying them? Posted by James Mickleboro has been a Motley Fool contributor since late 2015. After studying economics at university back home in the United Kingdom, James came to live in …

Source: The Motley Fool Australia - Neutral
Published on 03:48 GMT

Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring ...

SAN FRANCISCO and SUZHOU, China, May 29, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of …

Source: Macau Business - Pro-Government
Published on 01:02 GMT

Clinical Trial Monitoring: Should Randomization Be Included?

Developing a clinical trial’s effective monitoring plan can be overwhelming. The FDA acknowledges that while they require monitoring, their “regulations are not specific on how monitoring should be conducted.”1,2 Thus, it is challenging to understand what …

Source: Applied Clinical Trials - Pending
Published on 00:07 GMT

Reaction: FDA approves roflumilast foam 0.3% for scalp, body psoriasis

Last week, the FDA approved Arcutis Biotherapeutics' roflumilast foam 0.3% to treat plaque psoriasis of the scalp and body in patients aged 12 years and older, adding a nonsteroidal, once-daily, phosphodiesterase-4 inhibitor to the provider toolkit.1,2 …

Source: Contemporary Pediatrics - Pending
Published on May 28, 2025

HT-KIT Shows Activity in Rare KIT-Driven Cancers, Preclinical Data Finds

Preclinical data has shown compelling findings for HT-KIT, a proprietary antisense oligonucleotide therapy designed to silence aberrant KIT gene expression, among patients with rare and aggressive KIT-driven cancers, according to a news release from Hoth …

Source: Cure Today - Neutral

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Published on May 29, 2025 - 12:30 GMT

Pain Management Drugs Market to Hit $122.2Bn by 2033, Growing at 7.6% CAGR Amid Chronic Illness Surge|DataM Intelligence

The pain management drugs market will reach $122.28Bn by 2033, driven by chronic disease rise and innovation in non-opioid and targeted therapies. NEW YORK, NY, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Market Overview The Pain Management …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 12:30 GMT

Global General Anesthesia Drugs Market To Reach $6.08 Billion By 2029 With A Growth Rate Of 3.9%

The Business Research Company’s General Anesthesia Drugs Global Market Report 2025 – Market Size, Trends, And Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- How Significant is the Growth in the …

Distribution channels: Business & Economy, Companies ...

Published on May 29, 2025 - 12:45 GMT

Contract Pharma Packaging Market to Hit $26.59B By 2032 | DataM Intelligence

The Contract Pharma Packaging Market is projected to grow from USD 15.21 billion in 2024 to USD 26.59 billion by 2032, driven by rising outsourcing AUSTIN, TX, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Market Overview The Contract …

Distribution channels: Shipping, Storage & Logistics ...
Published on May 29, 2025 - 08:00 GMT

Prescription Pharmacy Bags Market Share Analysis Poised for Robust Growth Through 2035 Amid Healthcare Demand | FMI

Pharmacy bags boost branding, safety, and hygiene. Growth lies in AI, robotics, tamper-evident tech, and sustainable, biodegradable packaging solutions. NEWARK, DE, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- The prescription pharmacy bags market …

Distribution channels: Business & Economy ...

Published on May 29, 2025 - 12:30 GMT

Jay Glazer and Wife Rosie Glazer Offer Candid Look at ADHD and Relationships in New Qelbree® Content Series with ...

ROCKVILLE, Md., May 29, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals is expanding its partnership with TV personality and sports reporter Jay Glazer in a new content series featuring his wife, Rosie Glazer. The series, which launches its first episode …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on May 28, 2025 - 18:00 GMT

BestRx Pharmacy Software Announces Integration with Lansworth Pharma SelfServe’s Pharmaself24 Kiosk Solution

BestRx is pleased to announce a new integration with Lansworth Pharma SelfServe, an advanced automated prescription pickup solution. OAKBROOK, IL, UNITED STATES, May 28, 2025 /⁨EINPresswire.com⁩/ -- BestRx, a RedSail Technologies company and a leading …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 12:00 GMT

Cocrystal Pharma’s Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly ...

CC-42344 was shown to be highly active against the highly pathogenic 2024 Texas H5N1 avian influenza strain The Company’s virology study further confirmed the previous structural and in vitro data that revealed the binding of CC-42344 to PB2 protein of the …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 12:30 GMT

Clinical Trial Supply & Logistics Market Surges as Pharma Expands Global Trials | CAGR - 7.63% | DataM Intelligence

In-depth analysis of the clinical trial supply & logistics market, with insights into growth drivers, regions, companies, and recent U.S. & Japan news. AUSTIN, TX, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Clinical Trial Supply & …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

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Published on May 29, 2025 - 16:00 GMT

ICONIC NEW YORK BRANDS UNITE FOR YEAR TWO OF MEMORIAL SLOAN KETTERING CANCER CENTER’S NYC FOR MSK CAMPAIGN

Over 100 Participating Locations NEW YORK, NY, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Memorial Sloan Kettering Cancer Center (MSK) announces the return of NYC for MSK to celebrate MSK’s 141st anniversary. For one day, New York City’s most …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on May 29, 2025 - 15:44 GMT

6 State and Local Tax Trends That Are Evolving From The Wayfair Decision of 7 Years Ago

Conflicting nexus definitions and sales tax exemptions can result in inappropriate payments, often creating overpayments. PHILADELPHIA, PA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- In 2018, the United States Supreme Court decided the …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 29, 2025 - 15:29 GMT

Itiliti Health Digitizes Over 650 Medical Policies Across Four Lines of Business at Major Blues Plan

EDEN PRAIRIE, MN, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Itiliti Health, a leading innovator in prior authorization automation, is announcing the successful digitization of more than 650 medical policies, including carve-outs, across …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:25 GMT

Business Solutions Marketing Group Unlocks Key to Online Reputation: Announces ‘No Win, No Fee’ Review Removal Service

MECHANICSBURG, PA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Business Solutions Marketing Group, a leading digital marketing agency with over a decade of experience empowering small businesses, today unveiled a critical enhancement to its …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:22 GMT

Global Value-Based Healthcare Services Market Outlook 2025-2034: Growth Drivers, Share, And Trends

The Business Research Company’s Value-Based Healthcare Services Global Market Report 2025 - Market Size, Trends, And Global Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- The Business Research …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:22 GMT

Primary Driver In Surgical Sealants & Tissue Patches Market 2025: Rise In Sports Injuries From High-Impact Activities

The Business Research Company's Surgical Sealants And Tissue Patches Global Market Report 2025 – Market Size, Trends, And Global Forecast 2024-2033 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- The surgical …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:22 GMT

Sarcomatrix Selected as Finalist for Prestigious Start-Up Stadium at BIO International Convention 2025

BOSTON, MA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Sarcomatrix Therapeutics Corp., a pioneering biotech company developing oral, mutation-agnostic therapies for muscle-wasting diseases, has been selected as a finalist for the highly …

Distribution channels: Conferences & Trade Fairs, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:22 GMT

The Brookbush Institute Publishes NEW Article, Course, and Glossary Updates: 'Periodization Training: Who Needs It?'

The Brookbush Institute continues to enhance education with new courses, a modern glossary, an AI Tutor, and a client program generator. NEW YORK, NY, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Excerpt from the article: Periodization …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:21 GMT

Rising Demand For Neurological Disorders: A Key Driver Transforming The Synthetic Cannabinoids Market 2025

The Business Research Company's Synthetic Cannabinoids Global Market Report 2025 – Market Size, Trends, And Global Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- The global synthetic …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:21 GMT

Comprehensive Insights Of The Tendinopathy Market: Key Drivers, Trends, Growth Opportunities, And Forecast For 2025-2034

The Business Research Company's Tendinopathy Global Market Report 2025 – Market Size, Trends, And Global Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- The tendinopathy market will surge from $ …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 15:00 GMT

Trauma-Informed Parenting Workshop with Bryan Post Set for San Jose on June 12

SAN JOSE, CA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- On June 12, 2025, national trauma expert Bryan Post will lead a live, in-person From Fear to Love workshop in San Jose, California, as part of his 2025 World Tour. Known for …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 29, 2025 - 15:00 GMT

Sacramento Plastic Surgeon Compares Facial Rejuvenation Procedures

Charles Perry, MD, FACS – a plastic surgeon in Sacramento – compares various facial rejuvenation procedures, including brow lift surgery and blepharoplasty. SACRAMENTO, CA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- As a renowned plastic …

Distribution channels: Beauty & Hair Care, Companies ...
Published on May 29, 2025 - 15:00 GMT

Infocepts to Showcase Enterprise AI in Action at Databricks Data + AI Summit 2025

Join Infocepts at Booth F637 for live demos that bridge vision and execution with Databricks. SOUTH SAN FRANCISCO, CA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Infocepts, a global leader in AI-powered data solutions, is excited to …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on May 29, 2025 - 14:43 GMT

Global Thermal Spa And Wellness Market: Key Trends, Market Share, Growth Drivers, And Forecast For 2025-2034

The Business Research Company's Thermal Spa And Wellness Global Market Report 2025 – Market Size, Trends, And Global Forecast 2024-2033 LONDON, GREATER LONDON, UNITED KINGDOM, May 29, 2025 /⁨EINPresswire.com⁩/ -- The thermal spa and wellness …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 14:15 GMT

DOCS Outside the Box Welcomes Pediatric Provider, Leslie Mallett, ARNP, to Innovative Holistic Medical Team

Leslie Mallett, ARNP, brings 12 years of pediatric care experience and a passion for blending holistic and traditional medicine to support family wellness. ST. PETERSBURG, FL, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- DOCS Outside the …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 14:00 GMT

ReviveHealth™ Welcomes Gary Douville as COO to Lead Ops, Accelerate Tech and Advance Member Experience Amid Rapid Growth

A seasoned exec in digital health innovation and operational transformation, Douville brings proven leadership and a record of delivering impactful results. PONTE VEDRA, FL, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- ReviveHealth, Inc. ( …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 29, 2025 - 14:00 GMT

Tickets Now On Sale for Vivacity – Canada’s First Consumer Show for Medical Aesthetics, Longevity, and Healthy Aging

VANCOUVER, BRITISH COLUMBIA, CANADA, May 29, 2025 /⁨EINPresswire.com⁩/ -- Tickets are now on sale for Vivacity, a first-of-its-kind Canadian event designed to empower individuals with clear, science-based information on medical aesthetics, …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on May 29, 2025 - 14:00 GMT

Health Professional Student Association Earns 2025 Candid Platinum Seal of Transparency

Candid Seals of Transparency are awarded based on the amount and quality of information a nonprofit shares with the public via its Candid profile. HUNTINGTON BEACH, CA, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- The Health Professional …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on May 29, 2025 - 14:00 GMT

CD Bioglyco Unveils GlycoCLICK Solutions: A Powerful Platform for Streamlined Antibody Glycoengineering and Conjugation

NY, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- CD Bioglyco, a leading provider of glycobiology solutions, is pleased to introduce GlycoCLICK Solutions, a streamlined platform designed to empower scientists with precise, efficient, and …

Distribution channels: Chemical Industry, Companies ...
Published on May 29, 2025 - 14:00 GMT

Smarteeva Announces API Integration Support for FDA's Electronic Submissions Gateway Next Generation

The company became an early adopter of a new cloud-based submission system launched in April 2025. SOUTHLAKE, TX, UNITED STATES, May 29, 2025 /⁨EINPresswire.com⁩/ -- Smarteeva, a leading provider of AI-driven post-market surveillance solutions, …

Distribution channels: Business & Economy, Companies ...