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Published on 05:03 GMT

Access to funds and affordable treatments remain key challenges in Duchenne Muscular Dystrophy care in India

Duchenne muscular dystrophy (DMD), recognised by the World Health Organization (WHO) as a rare disease, is the most common form of childhood muscular dystrophy. It is a progressive genetic disorder that primarily affects boys, leading to gradual muscle …

Source: The Hindu - Center-left
Published on 00:32 GMT

Capricor’s DMD Cardiomyopathy Therapy to Face FDA Advisory Committee

The maker of an investigational cell therapy for Duchenne muscular dystrophy (DMD) says its lead product will go before an FDA advisory committee in advance of an expected late-summer approval decision from the agency. Capricor Therapeutics says it does …

Source: Managed Healthcare Executive - Neutral
Published on May 8, 2025

ASGCT 2025: CRISPR-Cas12 Editing Shows Early Clinical Benefit in Duchenne Muscular Dystrophy

At the upcoming annual meeting of the American Society of Cell and Gene Therapy, scientists from Huidagene Therapeutics will share an update on the development of their CRISPR-high-fidelity(hf)Cas12Max-based gene editing therapy for Duchenne muscular …

Source: Genetic Engineering & Biotechnology News -New York - Pending
Published on May 8, 2025

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily, use prescription drugs without sufficient evidence of their benefit and put patients at risk of side effects or other negative outcomes. The Food and Drug Administration …

Source: BioPharma Dive - Pending
Published on May 8, 2025

FDA Fast-Tracks Givinostat for Polycythemia Vera Treatment

The FDA has granted givinostat (Duvyzat) fast track status for the treatment of patients with polycythemia vera (PV). Givinostat is an orally administered histone deacetylase (HDAC) inhibitor. The agent is currently being assessed in the ongoing phase 3 …

Source: Targeted Oncology - Pending
Published on May 8, 2025

Trump’s diversity purge freezes hundreds of millions in medical research at universities across the country

(CNN) — Universities across the country are scrambling to comply with President Donald Trump’s anti-diversity push in an effort to hold on to hundreds of millions of dollars in federal grants that fund critical medical research in areas such as cancer and …

Source: Crossroads Today - Texas - Neutral
Published on May 8, 2025

Biotech Stocks Slide After FDA Selects Prasad to Lead CBER

The FDA’s Center for Biologics Evaluation and Research (CBER) will have a new director, as Vinay Prasad, MD, MPH, will fill the role following the resignation of Peter Marks, MD, PhD, 5 weeks ago.1 The leadership change was reported widely on Tuesday, …

Source: The American Journal of Managed Care - Neutral
Published on May 8, 2025

Vinay Prasad’s FDA Appointment ‘Anything But Status Quo’

Vinay Prasad is an oncologist and hematologist at the University of California, San Francisco, as well as a frequent health policy critic on his YouTube channel and various podcasts. Now, he can add chief of the FDA’s Center for Biologics Evaluation and …

Source: BioSpace - Pending
Published on May 7, 2025

Sarepta tries to quell concerns over DMD gene therapy Elevidys as patients delay treatment after death report

Sarepta Therapeutics CEO Doug Ingram opened the company’s first-quarter earnings call Tuesday by acknowledging that, like the broader biopharma industry, the genetic medicine biotech is facing a challenging time. Following report of a patient’s death after …

Source: Fierce Pharma - Neutral
Published on May 7, 2025

Sarepta shares plummet as lower sales outlook adds to gloom over FDA’s new biologics hire

Dive Brief: Sarepta Therapeutics shares slid 19% early Wednesday after the biotechnology company lowered its sales forecast for the year on the heels of a slower-than-expected first quarter for its top-selling product. Full-year product revenue will likely …

Source: BioPharma Dive - Pending
Published on May 7, 2025

Biotech stocks fall on Vinay Prasad news

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Biotech was not faring well yesterday, after we got the news that Vinay Prasad was chosen to be the next director of …

Source: STAT - Massachusetts - Neutral
Published on May 7, 2025

Dr. Vinay Prasad to Head FDA Vaccine, Biologics Division

Key Takeaways Dr. Vinay Prasad has been tasked to head the FDA’s biologics division Prasad has criticized the U.S. government's response to COVID-19 His new role has caused biotech stocks to drop more than 5% WEDNESDAY, May 7, 2025 (HealthDay News) — …

Source: The Citizen - Vermont - Neutral
Published on May 7, 2025

Sarepta shares fall amid FDA’s CBER appointment and weak Elevidys sales

Sarepta Therapeutics saw its stock drop by 26% on 6 May after the US Food and Drug Administration (FDA) announced that Vinay Prasad will lead its Center for Biologics Evaluation and Research (CBER), the division responsible for regulating gene therapies …

Source: Pharmaceutical Technology - Neutral
Published on May 6, 2025

Prasad’s FDA appointment pressures cell and gene therapy stocks

Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic of the speedy approval paths their treatments often rely on was named to lead the Food and Drug Administration office that regulates …

Source: BioPharma Dive - Pending
Published on May 5, 2025

FDA will ask outside experts to review Capricor’s therapy for Duchenne muscular dystrophy

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we explore how an ambitious nonprofit is taking control of a shelved gene therapy, as it seeks to create a new model for …

Source: STAT - Massachusetts - Neutral
Published on May 6, 2025

Givinostat Wins U.S. FDA Fast Track Designation for Patients With PV

Treatment with givinostat has received fast track designation from the United States Food and Drug Administration (FDA) for patients with polycythemia vera (PV), a rare blood cancer, for which treatment options are limited, according to a news release from …

Source: Cure Today - Neutral
Published on 00:44 GMT

St. Jude Neurologist Richard Finkel Included in TIME100 Health List

Richard S. Finkel, MD, a pioneering pediatric neurologist and director of the Center for Experimental Neurotherapeutics (CENT) at St. Jude Children’s Research Hospital, has been distinguished on Time Magazine’s TIME100 Health list for 2025. This …

Source: Bioengineer.org - Pending
Published on May 8, 2025

REGENXBIO Releases Schedule of Its ASGCT Oral Sessions and Poster Exhibits

REGENXBIO, a Rockville, Md.-based clinical-stage biotechnology company, is announcing its slate of oral and poster presentations to be made at the American Society of Gene & Cell Therapy (ASGCT)’s 28th annual meeting, which will be held in New Orleans …

Source: BioPharm International - Pending
Published on May 8, 2025

Forum: Make it easier for fans with disabilities to enjoy historic sporting moments

As a lifelong Singapore football fan, I was proud to follow the Lion City Sailors’ progression to the final of a prestigious continental competition (Lion City Sailors reach historic Asian Champions League Two final despite 1-0 defeat by Sydney FC, April …

Source: The Straits Times - Pro-Government

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Published on May 8, 2025 - 21:52 GMT

Meeting of the Oncologic Drugs Advisory Committee - 05/20/2025

Date: May 20 - 21, 2025 Day1: Tue, May 20 8:00 a.m. - 05:00 p.m. ET Day2: Wed, May 21 8:00 a.m. - 05:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 8, 2025 - 21:00 GMT

Apimeds Pharmaceuticals US, Inc. Announces Pricing of Initial Public Offering

Hopewell, New Jersey, May 08, 2025 (GLOBE NEWSWIRE) -- Apimeds Pharmaceuticals US, Inc. (NYSE American: APUS) (“Apimeds” or the “Company”), a clinical stage biopharmaceutical company that is in the process of developing Apitox, an intradermally …

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

Published on May 8, 2025 - 20:17 GMT

Fennec Pharmaceuticals to Report First Quarter 2025 Financial Results on May 13, 2025

RESEARCH TRIANGLE PARK, N.C., May 08, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will release its first quarter 2025 financial results …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 20:05 GMT

Terns Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Corporate Updates

Initiated dose expansion in Phase 1 CARDINAL trial of TERN-701 in 2L+ CML Additional safety and efficacy data including 6-month MMR expected in 4Q25 Phase 2 FALCON trial of TERN-601 for obesity is enrolling well with top-line 12-week weight loss data …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...

Published on May 8, 2025 - 20:05 GMT

Crinetics Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

Regulatory Interactions and Commercial, Medical, and Corporate Preparations On-Track for Paltusotine New Drug Application with September 25, 2025 PDUFA Date CALM-CAH Phase 3 Study of Atumelnant for the Treatment of Adults with Congenital Adrenal …

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Published on May 8, 2025 - 20:01 GMT

Shuttle Pharma FDA Orphan-Drug Nears Patient Enrollment Milestone for Phase 2 Clinical Trial

GAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 20:02 GMT

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2025 Financial Results

Soquelitinib data from cohorts 1-3 of atopic dermatitis Phase 1 clinical trial demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2 Phase 3 registrational clinical trial of …

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Published on May 8, 2025 - 20:01 GMT

Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for ...

Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2 Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

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Published on May 9, 2025 - 04:09 GMT

Tele911 Launches Fastest Path to Emergency Care in the U.S.

From Login to Live Board-Certified Emergency Room Physician in Under 40 Seconds PASADENA, CA, UNITED STATES, May 9, 2025 /⁨EINPresswire.com⁩/ -- In a bold step toward redefining emergency medical access, Tele911 today announced the launch of its …

Distribution channels: Emergency Services, Healthcare & Pharmaceuticals Industry ...
Published on May 9, 2025 - 04:03 GMT

Global Automated Cannabis Testing Market Set for Robust Growth, Projected to Achieve 11-13% CAGR from 2022 to 2032 | FMI

Automated Cannabis Testing Market Analysis – Growth & Trends 2022-2032 NEWARK, DE, UNITED STATES, May 9, 2025 /⁨EINPresswire.com⁩/ -- The global automated cannabis testing market is poised for significant expansion, with industry experts …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 9, 2025 - 04:03 GMT

Global Organ Transport Devices Market Poised for Growth to Reach USD 735.8 Million by 2035 at a CAGR of 4.9% | FMI

The Organ Transport Devices Market is segmented by devices, disposables, perfusion solutions, and region from 2025 to 2035 NEWARK, DE, UNITED STATES, May 9, 2025 /⁨EINPresswire.com⁩/ -- The global market for organ transport devices is witnessing …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 9, 2025 - 00:00 GMT

Renowned Neurosurgeon Dr. Mohana Rao (Dr. Rao) Chooses Guntur Over Global Metropolises, Revolutionizing Local Healthcare

Dr. Mohana Rao Patibandla's Quiet Revolution in Neurosurgery GUNTUR, ANDHRA PRADESH, INDIA, May 9, 2025 /⁨EINPresswire.com⁩/ -- Renowned Neurosurgeon Dr. Rao Chooses Guntur Over Global Metropolises, Revolutionizing Local Healthcare Dr. …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 8, 2025 - 23:32 GMT

Guardian Recovery Announces the Opening of Southern Maine Recovery Center in Westbrook, ME

Guardian Recovery, a leading provider of substance use disorder and mental health treatment announces the grand opening of Southern Maine Recovery Center. WESTBROOK, ME, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery, a …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on May 8, 2025 - 23:06 GMT

Guardian Recovery Welcomes Ross Bacon as Vice President of Business Development

Guardian Recovery announces the appointment of Ross Bacon as Vice President of Business Development bringing valuable expertise to support continued growth. DELRAY BEACH, FL, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 23:05 GMT

Guardian Recovery Announces Rebranding of Immersion Facilities in South Florida

Guardian Recovery announces the rebranding of two key treatment facilities in South Florida to further unify its expansive network of treatment facilities. DELRAY BEACH, FL, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery …

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Published on May 8, 2025 - 22:27 GMT

Stem Health Plus Specializes in Care for Chronic Skin Conditions

Stem Health Plus Offers Specialized Care for Chronic Skin Conditions WONDER LAKE, IL, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Stem Health Plus proudly announces its expanded focus on treating chronic skin conditions through advanced …

Distribution channels: Emergency Services, Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 22:24 GMT

Clean Remedies Announces Memorial Day Sale Honoring Veterans, Military, and Frontline Workers

Clean Remedies is proud to announce its upcoming Memorial Day Sale of 25% off sitewide, taking place from May 23 to May 26, 2025. AVON, OH, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Clean Remedies, a wellness company known for its plant- …

Distribution channels: Conferences & Trade Fairs, Consumer Goods ...
Published on May 8, 2025 - 22:21 GMT

Guardian Recovery's Chief Clinical Officer Featured on Huberman Lab Podcast

Ryan Soave, Chief Clinical Officer at Guardian Recovery, recently appeared as a guest expert on the influential Huberman Lab podcast. DELRAY BEACH, FL, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Ryan Soave, Chief Clinical Officer at …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 21:59 GMT

Guardian Recovery's New Pathway Counseling Centers Now In-Network With AmeriHealth

Guardian Recovery announces that their New Pathway Counseling Centers are now in-network with AmeriHealth insurance, expanding access to treatment services. PINE BROOK, NJ, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery …

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Published on May 8, 2025 - 21:50 GMT

Guardian Recovery - Montville Adolescent Center Now In-Network With AmeriHealth

Guardian Recovery announces that its Montville Adolescent Center is now in-network with AmeriHealth insurance, expanding access for adolescents. MONTVILLE, NJ, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery announces that its …

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Published on May 8, 2025 - 21:47 GMT

Comparing In-Office Teeth Whitening with Over-the-Counter Kits: What Sets Them Apart

SLIDELL, LA, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Teeth whitening remains one of the most requested cosmetic dental treatments in the United States. While over-the-counter whitening kits are widely available and often marketed as …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 21:11 GMT

Earth Buddy Offers CBD Products to Keep Pets Calm This Fourth of July

Earth Buddy is shining a light on the growing need for accessible education around using CBD for pets, especially when calming stressed-out pets. LONGMONT, CO, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Earth Buddy, a well-established pet …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on May 8, 2025 - 21:08 GMT

Guardian Recovery - Dallas Addiction Center Now In-Network with Magellan Health Insurance

Guardian Recovery's Dallas Addiction Center announces In-network Status With Magellan Health insurance, significantly enhancing treatment accessibility. DALLAS, TX, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Guardian Recovery's …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on May 8, 2025 - 20:50 GMT

WellMedica Pioneers Sexual Wellness Treatments for Men and Women

WellMedica offers non-surgical treatments that support men's and women’s sexual wellness, addressing erectile dysfunction and hormonal changes. RESTON, VA, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- In recent years, sexual wellness has …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on May 8, 2025 - 20:35 GMT

Pro Football Hall of Famer Terrell Davis Inspires Colorado Students and Promotes Schoolwide Mental Health Screening

DENVER, CO, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- On April 30, Super Bowl MVP and Pro Football Hall of Famer Terrell Davis visited Colorado’s Conifer High School to connect with students and launch the Rising Together Schoolwide Mental …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 8, 2025 - 20:17 GMT

Nurses Week 2025 in Full Swing: Team Select Home Care Kicks Off the Celebration with Gifts, Giveaways, and Gratitude

Team Select Home Care celebrates Nurses Week 2025 with giveaways, gifts, and gratitude for in-home nurses making a difference every day. PHOENIX, AZ, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Nurses Week 2025 is in full force, and …

Distribution channels: Business & Economy, Education ...
Published on May 8, 2025 - 20:05 GMT

Nutritionist Linda Lin Hosts 'Food Is Medicine' — A Wellness Experience Blending Science, Nutrition & Sound Healing

A hands-on evening of education and healing, featuring a nutrition talk, wellness insights, and an immersive sound bath—led by holistic nutritionist Linda Lin. SANTA MONICA, CA, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- Certified …

Distribution channels: Beauty & Hair Care, Culture, Society & Lifestyle ...
Published on May 8, 2025 - 20:00 GMT

Xoted Biotechnology Labs Holds Soft Launch at Spartanburg Community College’s Spark Center

Company’s ecosystem includes manufacturing and R&D facilities in South Carolina, Nevada and Tennessee NEW YORK, NY, UNITED STATES, May 8, 2025 /⁨EINPresswire.com⁩/ -- DRC Ventures, a global leader in biotech, nutraceutical, and environmental …

Distribution channels: Business & Economy, Companies ...