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Published on 18:23 GMT

UroGen Pharma Ltd. (URGN) Faces Securities Class Action Amid FDA’s Briefing Document and Subsequent ODAC Vote Against ...

SAN FRANCISCO, May 30, 2025 (GLOBE NEWSWIRE) -- A securities class action lawsuit styled Cockrell v. UroGen Pharma Ltd. et al., No. 3:25-cv-06088 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired UroGen …

Distribution channels: Consumer Goods, Law ...
Published on 16:55 GMT

Stealth Cuts 30% of Workforce Following FDA Rejection, Still Eyes Barth Approval

To help direct resources toward a potential new drug application resubmission for Barth syndrome therapy elamipretide, Stealth BioTherapeutics has laid off 30% of its workforce, the company announced May 29. The Needham, Massachusetts–based biotech did not …

Source: BioSpace - Pending
Published on 13:21 GMT

FDA rejects Stealth Bio’s Barth syndrome treatment after 16.5-month review

The US Food and Drug Administration (FDA) has rejected Stealth BioTherapeutics’ elamipretide for the treatment of Barth syndrome after a lengthy review. The complete response letter (CRL) issued by the FDA comes after a 16.5-month priority review cycle and …

Source: Pharmaceutical Technology - Pending
Published on 10:18 GMT

Eton Pharmaceuticals’ NDA for Khindivi receives US FDA nod for oral solution formulation

Eton Pharmaceuticals, Inc, an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the US Food and Drug Administration (FDA) approval of an NDA for Khindivi (hydrocortisone) oral solution as a …

Source: Pharmabiz.com - Neutral
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 29, 2025

'Hanging on by our fingernails': Stealth CEO questions efficiency behind FDA rejection of rare disease drug

After communicating with the FDA about font sizes for potential packaging on its investigational injection, Stealth Biotherapeutics’ CEO thought approval for the ultrarare genetic disease treatment was imminent. Instead, after more than 16 months under …

Source: Fierce Pharma - 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 May 29, 2025

FDA Grants Priority Review to Sevabertinib NDA in HER2+ Lung Cancer

The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a new drug application (NDA) for the investigational compound sevabertinib (BAY 2927088), in adult patients with previously treated, advanced non-small cell lung cancer …

Source: Cure Today - Neutral
Published on May 29, 2025

Sevabertinib Given FDA Priority Review for HER2+ NSCLC

The new drug application (NDA) seeking the approval of sevabertinib (BAY2927088) in previously treated HER2-positive non-small cell lung cancer (NSCLC) was granted priority review by the FDA, according to a press release from Bayer, the drug’s developer.1 …

Source: Oncology Nursing News - Pending
Published on May 29, 2025

Alcon Secures First FDA Approval Since Novartis Spin-Off In 2019

The U.S. Food and Drug Administration (FDA) on Wednesday approved Alcon Plc’s ALC Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for signs and symptoms of Dry Eye Disease (DED). Alcon produces contact lenses, dry eye drops, …

Source: Benzinga - Neutral
Published on May 29, 2025

FDA Approves Eton Pharma's Oral Drug For Adrenal Insufficiency In Pediatric Patients, Analyst Sees Boost In 2025 Revenue

The U.S. Food and Drug Administration (FDA) approved Eton Pharmaceuticals, Inc.’s ETON new drug application (NDA) for Khindivi (hydrocortisone) oral solution as a replacement therapy for pediatric patients five years of age and older with adrenocortical …

Source: Benzinga - Neutral
Published on May 29, 2025

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 May 29, 2025

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 15:25 GMT

URGN Investors Have the Opportunity to Lead the UroGen Pharma Securities Fraud Lawsuit with Faruqi & Faruqi, LLP

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $75,000 in UroGen between July …

Source: WFMZ - Pennsylvania - Neutral
Published on 10:05 GMT

URGN INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that UroGen Pharma Ltd. Investors with Substantial ...

SAN DIEGO, May 30, 2025 (GLOBE NEWSWIRE) -- The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, inclusive (the “Class Period”), …

Distribution channels: Consumer Goods, Law ...
Published on 15:53 GMT

Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against UroGen Pharma Ltd. (URGN)

NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of New Jersey on behalf of all persons or entities who purchased …

Distribution channels: Consumer Goods, Law ...
Published on 09:46 GMT

GSK & Spero Therapeutics announce PIVOT─PO phase III study for tebipenem HBr stopped early for efficacy following review ...

GSK plc and Spero Therapeutics announced that the pivotal phase III PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, will stop early for efficacy ( …

Source: Pharmabiz.com - Neutral
Published on 09:41 GMT

Porton Advanced Announces Collaboration With TongEYE To Accelerate Development Of iPSC-RPEC Transplantation Therapy

Suzhou, China /PRNewswire/ - Porton Advanced, a leading contract development and manufacturing organization (CDMO) specializing in advanced therapy medicinal products (ATMPs), is pleased to announce its partnership with TongEye Medical Technology ( …

Source: Outsourced Pharma - Pending
Published on 10:00 GMT

Zymeworks Announces NMPA Approval of Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic ...

Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2+ biliary tract cancer in China; conditional approval based on the results of the HERIZON-BTC-01 clinical study $20 million milestone payment to be received from …

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

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Published on May 30, 2025 - 12:48 GMT

Nasal Polyposis Drugs Market Size, Trends & Top Treatment Options 2025 | DataM Intelligence

The Global Nasal Polyposis Drugs Market is estimated to reach at a CAGR of 6.6% during the forecast period 2024-2031. AUSTIN, TX, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Market Overview: The Global Nasal Polyposis Drugs Market is expanding …

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

Prescription Drugs Market to Reach USD 2.15 Trillion by 2031, Driven by Innovation and Demand | DataM Intelligence

Prescription drug market expands rapidly due to AI in pharma, rising diseases, and global access to advanced therapies. AUSTIN, TX, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- The global prescription drugs market is experiencing robust …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

Published on May 30, 2025 - 12:45 GMT

IgA Nephropathy Drugs Market to Grow at 18.1% CAGR Driven by Biologic Innovations and FDA Approvals| DataM Intelligence

The IgA Nephropathy drugs market is set for 18.1% CAGR growth, led by biologics, FDA approvals, and major pharma R&D efforts worldwide. NEW YORK, NY, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Market Overview: The IgA Nephropathy …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 03:48 GMT

Temperature Controlled Pharma Packaging Market to Double by 2035, Reaching USD 29,859.1 Million Amid Biologics Boom

Japan’s pharma industry boosts cold chain use for biologics, using advanced temp-controlled packaging and smart tech, with a 7.5% CAGR from 2025 to 2035. NEWARK, DE, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- The Temperature Controlled …

Distribution channels: Business & Economy ...

Published on May 30, 2025 - 16:34 GMT

Class Action Filed Against West Pharmaceutical Services, Inc. (WST) - July 7, 2025 Deadline to Join – Contact Levi & ...

NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in West Pharmaceutical Services, Inc. ("West Pharmaceutical Services, Inc." or the "Company") (NYSE: WST) of a class action securities lawsuit. …

Distribution channels: Consumer Goods, Media, Advertising & PR ...
Published on May 30, 2025 - 18:23 GMT

UroGen Pharma Ltd. (URGN) Faces Securities Class Action Amid FDA’s Briefing Document and Subsequent ODAC Vote Against ...

SAN FRANCISCO, May 30, 2025 (GLOBE NEWSWIRE) -- A securities class action lawsuit styled Cockrell v. UroGen Pharma Ltd. et al., No. 3:25-cv-06088 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired UroGen …

Distribution channels: Consumer Goods, Law ...
Published on May 30, 2025 - 14:08 GMT

Grabar Law Office Investigates Claims on Behalf of Long-Term Shareholders of DoubleVerify Holdings, Inc. (NYSE: DV); ...

PHILADELPHIA, May 30, 2025 (GLOBE NEWSWIRE) -- DoubleVerify Holdings, Inc. (NYSE: DV): If you have held DoubleVerify Holdings, Inc. (NYSE: DV) shares since prior to November 10, 2023, and would like to learn more about the investigation and your rights, …

Distribution channels: Business & Economy, Law ...
Published on May 30, 2025 - 13:14 GMT

PharmAla Biotech Warns Against Fake Products Claiming to be Made by PharmAla

TORONTO, May 30, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA ( …

Distribution channels: Environment, Healthcare & Pharmaceuticals Industry ...

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Published on May 30, 2025 - 19:00 GMT

A New Initiative for the Wellness of Children and Communities: A Mental Health Awareness Event with U.S. - Japan Experts

～Heartfulness × Hip-Hop Therapy × Expressive Arts Therapy ～“M.O.F.U.” to Be Held for the First Time in Katsushika, Tokyo TOKYO, CA, JAPAN, May 30, 2025 /⁨EINPresswire.com⁩/ -- On Saturday, June 7, 2025, a mental health awareness event titled“M.O.F …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 30, 2025 - 18:40 GMT

Media Statement By Dr. Gail C. Christopher: America 5 Years After George Floyd’s Murder

Dr. Christopher, leader of the National Collaborative for Health Equity, says racial justice faces headwinds, but accomplishments have not been erased WASHINGTON, DC, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Five years ago, at the …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 30, 2025 - 18:28 GMT

Cosmetic Dentistry Experts Drs. John and Jade Moreau of Unforgettable Smiles Talk How Enhanced Smiles Build Confidence

ALEXANDRIA, LA, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Drs. John and Jade Moreau of Unforgettable Smiles is featured in the latest edition of HelloNation, where he shares valuable insight on the role of cosmetic dentistry in improving both …

Distribution channels: Beauty & Hair Care, Business & Economy ...
Published on May 30, 2025 - 18:23 GMT

Efferent Labs Announces Patents in South Korea, Europe & Mexico, Expanding Global IP Protection for CytoComm® Platform

Efferent Labs expands global IP with new patents in South Korea, Europe & Mexico, strengthening protection for its CytoComm® preclinical biosensor platform. MOUNT PLEASANT, SC, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Efferent Labs, …

Distribution channels: Companies, Education ...
Published on May 30, 2025 - 16:38 GMT

Diagnostic BioSystems Inc. receives SFDA approval for its extensive IHC Product portfolio

Diagnostic BioSystems Inc. USA announces the approval for its Extensive portfolio of IHC products by the Saudi Food and Drug Authority (SFDA) PLEASANTON, CA, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Diagnostic BioSystems Inc. (DBS), a …

Distribution channels: Chemical Industry, Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 16:36 GMT

Medloft Spa Announces Soft Opening for Alabama with $12,000 Makeover Giveaway

The medical spa franchise will be opening its very first Alabama location this weekend. HUNTSVILLE, AL, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Medloft Spa, an innovative wellness spa offering advanced non-invasive services, will hold …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 16:32 GMT

Five Heat Exhaustion Cases Reported Among Pilgrims; All in Stable Condition

MAKKAH, SAUDI ARABIA, May 30, 2025 /⁨EINPresswire.com⁩/ -- Saudi Arabia’s Ministry of Health has confirmed five cases of heat exhaustion among pilgrims performing Hajj rituals amid rising temperatures in the holy sites. All individuals …

Distribution channels: Book Publishing Industry, Business & Economy ...
Published on May 30, 2025 - 16:21 GMT

Christian Health Expert Ondrea Lynn Empowers Women with Bold New Book on Faith-Based Weight Loss Strategy

With a mission to help Christian women reclaim their health and rise into their God-given purpose! HIGHLAND, NY, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Christian women across the globe are about to gain a powerful new tool in their …

Distribution channels: Book Publishing Industry, Culture, Society & Lifestyle ...
Published on May 30, 2025 - 15:49 GMT

Advanced Obstetrics & Gynecology, LLC Celebrates Major Expansion and Ongoing Excellence in Women’s Healthcare Across NJ

Advanced Obstetrics & Gynecology, LLC, a cornerstone of women’s healthcare in Central New Jersey, proudly announces its recent growth. FLEMINGTON, NJ, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Advanced Obstetrics & Gynecology, …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 15:17 GMT

Touchpoints Launches LinQed Online to Transform Benefits Communication and Employee Engagement

A white-labeled platform that unifies email, SMS, push, and strategy to simplify benefits communication and boost workforce engagement. HOUSTON, TX, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Touchpoints, a leader in strategic employee …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 15:04 GMT

Truck Accidents Are a Leading Cause of Traumatic Pregnancy Injuries in the U.S.

Traumatic pregnancies caused by truck and car accidents are on the rise. Zinda Law Group provides critical legal insight to pregnant crash victims. AUSTIN, TX, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Traumatic pregnancies caused by …

Distribution channels: Emergency Services, Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 15:00 GMT

HSA for America Welcomes Three New Personal Benefits Managers Amid Growing Healthcare Complexity

As healthcare options grow more complex, HSA for America expands team to provide clearer guidance and personal support. FORT COLLINS, CO, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- In response to rising healthcare costs and growing demand …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 30, 2025 - 15:00 GMT

Supervised Exercise Therapy Offers a Cost-Effective Solution to the Nation’s Chronic Disease Crisis

New study led by Physical Activity Alliance and American Heart Association reveals health and economic benefits of community-based programs. WASHINGTON, DC, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- As chronic disease rates and …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 15:00 GMT

Evident Launches EviSmart Comm to Streamline Case Communication Between Labs and Dentists

VANCOUVER, BRITISH COLUMBIA, CANADA, May 30, 2025 /⁨EINPresswire.com⁩/ -- Evident, a provider of digital dental workflow solutions, today announced the release of EviSmart Comm, a new module in the EviSmart platform designed to simplify and …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 15:00 GMT

The Brookbush Institute Publishes NEW Course: Acute Variables: Periodization Training

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 30, 2025 /⁨EINPresswire.com⁩/ -- - Related Course: Acute Variables: …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 14:00 GMT

CABS Health Network and CookUnity Launch Medicaid Meal Initiative to Tackle Food Insecurity in New York City

BROOKLYN, NY, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- CABS Health Network is proud to announce a groundbreaking partnership with CookUnity, the only premium 100% chef-crafted meal delivery service, to launch a new Medicaid-covered …

Distribution channels: Business & Economy, Consumer Goods ...
Published on May 30, 2025 - 13:24 GMT

Disposable Flexible Duodenoscope Market projected to achieve a CAGR of 7.09% to reach US$1,940.754 million by 2030

The disposable flexible duodenoscope market is anticipated to grow at a CAGR of 7.09% from US$1,377.901 million in 2025 to US$1,940.754 million by 2030. NEW YORK, NY, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- According to a new study …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 13:19 GMT

Frontotemporal Dementia Therapeutics Enter New Era as Gene and Antibody Therapies Advance Toward Market | CI Insights

FTD therapies are evolving fast, led by gene-targeted innovation and Phase III trials aiming to modify the disease, not just manage symptoms. AUSTIN, TX, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Frontotemporal dementia (FTD), a rare and …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 30, 2025 - 13:15 GMT

Colorectal Cancer Alliance Honors Survivors, Encourages Screening and Advocates for Research During Survivors Month

Alliance Survey Reveals Most Americans Deprioritize Colorectal Cancer Screening, Yet Screening & Innovative Research are Critical to Survivorship WASHINGTON, DC, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- In recognition of National …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on May 30, 2025 - 13:15 GMT

Digital Radiography Systems Market Set for 4.2% Growth, Fueled by AI & Portability (2024–2031) | DataM Intelligence

The digital radiography systems market is growing at 4.2% CAGR through 2031, driven by AI integration, portability, and healthcare digitization trends. NEW YORK, NY, UNITED STATES, May 30, 2025 /⁨EINPresswire.com⁩/ -- Market Overview The …

Distribution channels: Healthcare & Pharmaceuticals Industry ...