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Published on May 2, 2025

FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan

Cytokinetics aims to compete with a Bristol Myers Squibb heart drug projected to become a blockbuster seller, and the company’s value proposition is that its drug candidate has a potential safety edge. The biotech needs to wait a little longer to see what …

Source: MedCity News - Neutral
Published on May 2, 2025

OcuSciences gains FDA clearance on retinal health scanner

The US Food and Drug Administration (FDA) has cleared OcuSciences’ retinal health assessment device, OcuMet Beacon. The non-invasive device is indicated for ophthalmoscope scanning for infrared and autofluorescence imaging of the retina, with or without …

Source: Medical Device Network - Neutral
Published on May 2, 2025

US FDA accepts Novo Nordisk’s application for oral Wegovy for weight loss

(Reuters) -The U.S. Food and Drug Administration has accepted Novo Nordisk’s marketing application for an oral version of its weight-loss drug Wegovy and will take a decision by the fourth quarter, the Danish drugmaker said on Friday. The company’s …

Source: Regional Media News - Iowa - Pending
Published on May 2, 2025

FDA to Rehire Some Travel Staff as Lapses Begin to Show: AP

The FDA is considering bringing back about 20 of its fired employees who made travel arrangements for the agency’s inspectors, according to a Thursday report from the Associated Press. Citing FDA staff with knowledge of the rehiring plans—and who were …

Source: BioSpace - Pending
Published on May 2, 2025

FDA resurrects Satsuma's nasal migraine treatment

More than a year after it was rejected by the FDA, Satsuma Pharma's intranasal migraine therapy Atzumi (formerly STS101) has been given the go-ahead by the agency. The drug – a new dry powder intranasal formulation of the well-established migraine …

Source: pharmaphorum - Neutral
Published on May 2, 2025

Bavarian Nordic Receives Marketing Authorization For Chikungunya Vaccine For Persons Aged 12 And Older In The United ...

(MENAFN- GlobeNewsWire - Nasdaq) COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) …

Source: MENAFN - Indeterminate
Published on May 1, 2025

FaceHeart Received Another FDA Clearance for its Contactless Video-Based Vital Sign Measurement of Respiratory Rate

Developed by FaceHeart, FH Vitals SDK-RR has obtained FDA Clearance. This is the second 510(k) class II SaMD (Software as a Medical Device) FaceHeart received from the FDA. FaceHeart Vitals™ is a video-based, contactless vital sign measurement SDK that can …

Source: The Laotian Times - Indeterminate
Published on May 1, 2025

4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME

EMERYVILLE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on May 1, 2025

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

Q32 Bio, of Waltham, Mass., announced on April 30, 2025 that its human anti-IL-7Rα antibody, bempikibart (ADX-914), has been given fast track designation by FDA for the treatment of alopecia areata (AA) (1). According to the National Alopecia Areata …

Source: Pharmaceutical Technology - Neutral
Published on Apr 30, 2025

Business Bites: FDA may end self-affirmed GRAS, sparking industry debate

U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has instructed acting Food and Drug Administration (FDA) Commissioner Sara Brenner to review the self-affirmed GRAS (generally recognized as safe) pathway to ingredient approval, with the …

Source: Food & Beverage Insider - Pending
Published on Apr 30, 2025

ASX Health Quarterly Wrap: Control Bionics reports strong US revenue, LTR Pharma makes FDA progress

LTR Pharma held a successful pre-IND meeting with the US FDA during the March quarter. Pic: Getty Images Special Report: ASX quarterly season is upon us again, with listed companies opening a window to their performance and key activities over the three …

Source: Stockhead - Neutral
Published on Apr 30, 2025

Q32 Bio’s Bempikibart Receives FDA Fast Track Designation for Alopecia Areata

Today, Q32 Bio announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for bempikibart (ADX-914), which is used for the treatment of severe alopecia areata.1 "The Fast Track designation granted by the FDA …

Source: Dermatology Times - Neutral
Published on Apr 30, 2025

Linvoseltamab Wins European Approval Despite FDA Rejection

Regeneron’s bispecific antibody linvoseltamab has received conditional approval from the European Commission (EC) for use in relapsed or refractory multiple myeloma. The decision comes just eight months after the drug was rejected by the FDA due to …

Source: Technology Networks - Neutral
Published on Apr 30, 2025

Elamipretide to treat Barth syndrome sees FDA target action delay

This week, Stealth BioTherapeutics Inc. announced that the FDA did not meet the April 29, 2025, Prescription Drug User Fee Action (PDUFA) date for elamipretide's new drug application (NDA) to treat Barth syndrome.1 According to a press release from …

Source: Contemporary Pediatrics - Pending
Published on Apr 30, 2025

FDA Delays Decision on Elamipretide for Barth Syndrome

The US Food and Drug Administration (FDA) delayed the target action date for the New Drug Application (NDA) for the investigational medicine, elamipretide, for the treatment of Barth syndrome.1 Announced on April 30, 2025, Stealth BioTherapeutics indicated …

Source: Consultant Live - Pending
Published on Apr 30, 2025

FDA looking to ban petroleum-based synthetic dyes from foods; Virginia Tech expert shares thoughts

BLACKSBURG, Va. (WDBJ) - Earlier this year, the Food and Drug Administration (FDA) banned the use of Red No. 3 dye in foods. This is after it was found to cause cancer in lab rats. Now the organization is looking to take action on even more common dyes …

Source: WDBJ7 - Virginia - Pending
Published on Apr 30, 2025

FDA approves AbbVie’s upadacitinib for giant cell arteritis

The US Food and Drug Administration (FDA) has granted approval for AbbVie’s 15mg Rinvoq (upadacitinib) to treat adults with giant cell arteritis (GCA). The approval follows the recent marketing authorisation granted by the European Commission for the same …

Source: Pharmaceutical Technology - Pending
Published on Apr 30, 2025

XORTX Provides Update on FDA Type B Meeting Request

● XORTX will focus on key steps to advance a NDA filing for Gout indication ● CALGARY, Alberta, April 30, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on Apr 30, 2025

UK MHRA grants marketing approval for BridgeBio Pharma's Beyonttra to treat ATTR─CM

BridgeBio Pharma, Inc., a new type of biopharmaceutical company focused on genetic diseases, announced the Medicines and Healthcare products Regulatory Agency has granted marketing authorization in the United Kingdom (UK) for acoramidis, under the brand …

Source: Pharmabiz.com - Neutral

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Published on May 2, 2025 - 15:00 GMT

Launch of Hokkaido’s First Regional Specialized Influencer Marketing Service

Bringing Hokkaido's Charm to the World to Boost the Economic Vitality and Community Pride SHIBUYA-KU, TOKYO, JAPAN, May 2, 2025 /⁨EINPresswire.com⁩/ -- TSUTA-WORLD Inc.(Headquarters: Shibuya Ward, Tokyo; Branch Office: Sapporo City, Hokkaido; …

Distribution channels: Media, Advertising & PR, Travel & Tourism Industry ...
Published on May 2, 2025 - 16:46 GMT

WildGrowthControl Launches AI Marketing Funnel to Boost Local Service Business Growth

AI-powered platform helps local service businesses automate lead capture, boost conversions, and dominate local search visibility. NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- WildGrowthControl, a forward-thinking digital solutions …

Distribution channels: Business & Economy, Companies ...

Published on May 2, 2025 - 19:39 GMT

Digital Marketing Leadership: Bob Bartosiewicz of CGI Digital Shares Insights on Civic Innovation in HelloNation

THOMASTON, CT, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- What does it take to transform a local enterprise into a national digital force without leaving your hometown behind? Bob Bartosiewicz, founder and CEO of CGI Digital, provides an …

Distribution channels: Business & Economy, Companies ...
Published on May 2, 2025 - 08:05 GMT

CloudLinux Names Aleksandra Mitroshkina as Vice President of Marketing for Imunify Security and CloudLinux OS Brands

CloudLinux strengthens its executive leadership team with the addition of experienced product marketing leader PALO ALTO, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- CloudLinux, the company behind secure and scalable operating systems …

Distribution channels: IT Industry ...

Published on May 2, 2025 - 04:41 GMT

Book Writers Hub Elevates Author Success with Comprehensive Publishing and Marketing Services

NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- New York-based literary services company Book Writers Hub is excited to announce the enhancements of its book publishing and promotional services. Dedicated to enabling writers and …

Distribution channels: Book Publishing Industry ...
Published on May 1, 2025 - 23:52 GMT

Basement Talk to Big Leagues - How Zill Media Became a Powerhouse Marketing Agency in Sports, Culture & Entertainment

IRVINE, CA, UNITED STATES, May 1, 2025 /⁨EINPresswire.com⁩/ -- What started as a podcast in a basement has grown into one of the most talked-about creative marketing agencies in the game. Founded by Kyler Isaoglu in 2020, and later joined by his …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on May 2, 2025 - 09:30 GMT

Best Email Service For Business (2025): Klaviyo Awarded Top Email Marketing Software by Software Experts

NEW YORK CITY, May 02, 2025 (GLOBE NEWSWIRE) -- Software Experts has named Klaviyo one of the top email marketing platforms of the year. Klaviyo’s AI-powered automation, real-time customer data integration, and multi-channel marketing capabilities position …

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Published on May 2, 2025 - 09:00 GMT

Best Marketing Automation Tools (2025): Klaviyo Named Top Marketing Tool by Expert Consumers

NEW YORK CITY, May 02, 2025 (GLOBE NEWSWIRE) -- Expert Consumers has named Klaviyo a top marketing tool for 2025. Recognized for its ability to integrate marketing automation, data-driven personalization, and omnichannel engagement, Klaviyo has become an …

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Published on May 3, 2025 - 00:35 GMT

Miami Strategic Intelligence Institute Establishes Collaboration with FinGurú

FinGurú and MSI² Seek to Enhance Strategic Information, Innovation, and Expert Analysis MIAMI, FL, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Miami Strategic Intelligence Institute (MSI²), a conservative, nonpartisan think tank founded …

Distribution channels: Business & Economy, Media, Advertising & PR ...
Published on May 3, 2025 - 00:35 GMT

Miami Strategic Intelligence Institute establece colaboración con el medio FinGurú

FinGurú y MSI² buscan potenciar información estratégica, innovación y análisis de expertos MIAMI, FL, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- El Miami Strategic Intelligence Institute (MSI²), think tank conservador y no partidista …

Distribution channels: Business & Economy, Media, Advertising & PR ...
Published on May 2, 2025 - 23:16 GMT

CloudOffix to Exhibit at GITEX EUROPE 2025 in Berlin, Showcasing the Future of Total AI, Low-Code, and Total Experience

CloudOffix to Exhibit at GITEX EUROPE 2025 in Berlin, Showcasing the Future of Total AI, Low-Code, and Total Experience CLAYMONT, DE, UNITED STATES, May 3, 2025 /⁨EINPresswire.com⁩/ -- CloudOffix, the world’s first and most comprehensive Low-Code …

Distribution channels: Automotive Industry, Aviation & Aerospace Industry ...
Published on May 2, 2025 - 23:16 GMT

CloudOffix Accelerates Global Expansion with New Strategic Partnerships in Europe and MENA

CloudOffix Accelerates Global Expansion with New Strategic Partnerships in Europe and MENA CLAYMONT, DE, UNITED STATES, May 3, 2025 /⁨EINPresswire.com⁩/ -- CloudOffix, the pioneering low-code Total Experience Platform, announces plans to …

Distribution channels: Business & Economy, Companies ...
Published on May 2, 2025 - 23:11 GMT

CloudOffix Launches AI Workshop Series to Empower Enterprises with Total AI

CloudOffix Launches AI Workshop Series to Empower Enterprises with Total AI CLAYMONT, DE, UNITED STATES, May 3, 2025 /⁨EINPresswire.com⁩/ -- CloudOffix, the world’s first and only low-code Total Experience Platform, proudly announces the launch of …

Distribution channels: Automotive Industry, Banking, Finance & Investment Industry ...
Published on May 2, 2025 - 21:13 GMT

Coming Home to Lemuria: Charmian Redwood Offers a Spiritual Map to Rediscover Ancient Wisdom Today

Hypnotherapist Charmian Redwood unveils a soul-stirring journey to Lemuria, guiding readers to remember their purpose and raise Earth’s vibration SAN FRANCISCO, CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- In her illuminating new book, …

Distribution channels: Media, Advertising & PR, Religion ...
Published on May 2, 2025 - 20:46 GMT

Meagan Nugent selected as Top Professional Choreographer and Dancer by IAOTP

Meagan Nugent will be honored at the International Association of Top Professionals (IAOTP) Annual Awards Gala in Las Vegas NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Meagan Nugent, Creative and Choreographer at NU …

Distribution channels: Culture, Society & Lifestyle, Media, Advertising & PR ...
Published on May 2, 2025 - 20:44 GMT

Gailey Enterprises Real Estate Announces the 2025 Elite Circle Honorees

Celebrating Excellence in Real Estate Across Georgia and Florida OCALA, FL, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Gailey Enterprises Real Estate (GERE), a powerhouse in the real estate industry with over three decades of unmatched …

Distribution channels: Banking, Finance & Investment Industry, Culture, Society & Lifestyle ...
Published on May 2, 2025 - 20:42 GMT

Planet TV Studios to Feature Avtron Power Solutions’ Impact on Data Centers in New Frontiers Episode, Airing Q3 2025

Planet TV Studios proudly serves as the exclusive sponsor of the New Frontiers series. "New Frontier in Data Centers" airs Q3 2025 . CLEVELAND, OH, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Planet TV Studios announced today it …

Distribution channels: Consumer Goods, IT Industry ...
Published on May 2, 2025 - 20:31 GMT

NIA RENEE, RECENTLY SELECTED AS TOP DV ADVOCATE OF THE YEAR BY IAOTP

Nia Renee will be honored at the International Association of Top Professionals (IAOTP) annual awards gala in Las Vegas NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Nia Renee, was recently selected as Top DV Advocate of the …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on May 2, 2025 - 20:29 GMT

New York Art Life Presents Janette Oh Who Rewrites Couture’s Rulebook: Where Scrap Fabric Sparks a Style Uprising

CHELSEA, MANHATTAN, NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- In a world where the environmental impact of fashion casts a shadow, Janette Oh is a game-changer, redesigning waste into high-end fashion that combines cutting-edge …

Distribution channels: Culture, Society & Lifestyle, Media, Advertising & PR ...
Published on May 2, 2025 - 20:20 GMT

Fritz R. Franke Releases Groundbreaking First Book in 'The Savior Project' Series - 'The Chosen One'

Unveiling Destiny: "The Chosen One" Launches Readers into a Saga of Cosmic Proportions and Hidden Truths CA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Esteemed author Fritz R. Franke is thrilled to announce his book "The Chosen One …

Distribution channels: Education, Media, Advertising & PR ...
Published on May 2, 2025 - 19:39 GMT

Digital Marketing Leadership: Bob Bartosiewicz of CGI Digital Shares Insights on Civic Innovation in HelloNation

THOMASTON, CT, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- What does it take to transform a local enterprise into a national digital force without leaving your hometown behind? Bob Bartosiewicz, founder and CEO of CGI Digital, provides an …

Distribution channels: Business & Economy, Companies ...
Published on May 2, 2025 - 19:07 GMT

SCOTT & RENEE BAIO SELECTED AS TOP ADVOCATES & HUMANITARIANS OF THE YEAR BY IAOTP

Scott & Renee Baio will be honored at the International Association of Top Professionals (IAOTP) annual awards gala in Las Vegas NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Scott Baio & Renee Baio were recently …

Distribution channels: Media, Advertising & PR, Movie Industry ...
Published on May 2, 2025 - 19:00 GMT

AST Announces the Return of the IP3 for 2025 – A Unique Patent Purchase and Licensing Opportunity for Patent Owners

AST announces its tenth annual Industry Patent Purchase and Licensing Program - IP3 2025, connecting patent owners with major global technology firms. PRINCETON, NJ, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Allied Security Trust (AST) is …

Distribution channels: Automotive Industry, Banking, Finance & Investment Industry ...
Published on May 2, 2025 - 18:53 GMT

Country Music Legend Dave Caley Celebrates 45 Years of Top Hits

Celebrated Nashville recording artist Dave Caley reflects on four decades of music with acclaimed new country hits and a legacy of authenticity. NASHVILLE, TN, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- After 45 years of songwriting, …

Distribution channels: Book Publishing Industry, Culture, Society & Lifestyle ...
Published on May 2, 2025 - 18:34 GMT

Teresa Mirabella-Moran Selected as Top President and Chief Creative Officer of the Year by IAOTP

Teresa Mirabella Moran honored member of the International Association of Top Professionals (IAOTP) will be honored at their annual awards gala in Las Vegas NEW YORK, NY, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Teresa Mirabella-Moran, …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 2, 2025 - 18:13 GMT

Pennsylvania Dental Association Installs Dr. Theodore Rockwell as President

HARRISBURG, PA, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- The Pennsylvania Dental Association (PDA) recently installed Dr. Theodore J. Rockwell of Clarion as its 2025-2026 president, during its annual business meeting on April 26 at The …

Distribution channels: Healthcare & Pharmaceuticals Industry, International Organizations ...
Published on May 2, 2025 - 18:10 GMT

GRAND OPENING: ADEGA GAUCHA BRINGS BRAZILIAN CULINARY EXCELLENCE TO DEERFIELD BEACH

South Florida Welcomes Adega Gaucha: A New Chapter in Brazilian Culinary Excellence DEERFIELD BEACH, FL, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Adega Gaucha Brazilian Steakhouse celebrated the grand opening of its third Florida …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 2, 2025 - 18:07 GMT

Zach Theater Announces 5-Year Strategic Vision Along With A Fresh New Look

AUSTIN, TX, UNITED STATES, May 2, 2025 /⁨EINPresswire.com⁩/ -- Zach Theater, Texas’ longest-running professional theater, unveils a bold new look alongside a 5-year strategic plan aimed at making investments in education, artists development and …

Distribution channels: Amusement, Gaming & Casino, Companies ...