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Published on May 13, 2026

Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay

> Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart Moments after recording this episode of The Weekly, FDA Commissioner Marty Makary announced his resignation. Reports first circulated last Friday that …

Source: BioSpace - Pending
Published on May 12, 2026

A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

A rare type of cancer affecting the bile ducts of the liver now has its first FDA-approved targeted treatment, an intravenously infused medicine from Partner Therapeutics. The Friday regulatory decision for the drug, Bizengri, permits its use for treating …

Source: MedCity News - Neutral
Published on May 11, 2026

FDA Approves Lannett, Lanexa Biologics, and Sunshine Lake Pharma’s Interchangeable Insulin Glargine Biosimilar

On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved …

Source: JD Supra - California - Neutral
Published on May 11, 2026

Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher

The FDA has approved the use of Partner Therapeutics’ Bizengri to treat patients with cholangiocarcinoma carrying a specific genetic mutation—a decision that came just days after the drug was awarded the regulator’s national priority voucher. Bizengri, a …

Source: BioSpace - Pending
Published on May 11, 2026

FDA Seeks Advice on Researching Drug Risks in Pregnancy

US regulators are seeking to expand the knowledge base about potential side effects of medicines when taken during pregnancy because clinicians and their patients have long been concerned about the lack of information in this field. Speaking on May 8 at a …

Source: Medscape - Neutral
Published on 02:20 GMT

New mRNA adjuvant dramatically boosts T-cell vaccine responses in mice

MIT engineers have developed a new way to amplify the T-cell response to mRNA vaccines - an advance that could lead to much more powerful cancer vaccines and stronger protection against infectious diseases. Most vaccines generate both antibodies and T …

Source: Medical News - Neutral
Published on May 13, 2026

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) Q1 2026 Earnings Call Transcript

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) Q1 2026 Earnings Call Transcript May 9, 2026 Operator: Hello, everyone. Thank you for joining us, and welcome to Ligand’s First Quarter 2026 Earnings Call. [Operator Instructions] I will now hand the …

Source: Insider Monkey - Neutral
Published on May 13, 2026

A new approach to cancer vaccination yields more powerful T cells

MIT engineers have developed a new way to amplify the T-cell response to mRNA vaccines — an advance that could lead to much more powerful cancer vaccines and stronger protection against infectious diseases. Most vaccines generate both antibodies and T …

Source: MIT - Neutral
Published on May 8, 2026

6 FDA Headlines You Missed in April 2026

Welcome back to our recap of this month’s news and updates from the US Food and Drug Administration (FDA)! April 2026 was a busy month for the FDA, with several major new approvals and expanded indications taking center stage. Everything from diabetes to …

Source: Consultant Live - Pending
Published on May 8, 2026

FDA slowdown on Tzield sBLA underlines CNPV questions

Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions …

Source: BioWorld - Pending
Published on May 7, 2026

Sanofi Pulls Diabetes Drug Tzield from USFDA Fast-Track Review Amid Safety Concerns: Report

The move comes after the director of the FDA's Center for Drug Evaluation and Research, Tracy Beth Hoeg, disagreed with a staff decision to approve ‌the drug, ⁠teplizumab, the ⁠report said, citing sources familiar with the dispute. Teplizumab, branded …

Source: Medical Dialogues - Indeterminate
Published on May 8, 2026

STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more

Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. …

Source: STAT - Massachusetts - Neutral
Published on May 7, 2026

Sanofi asks to pull diabetes drug out of FDA voucher program

Bengaluru: Sanofi has asked the U.S. Food and Drug Administration to pull its diabetes drug out of the regulator's new fast-track review program, STAT News reported on Wednesday. The move comes after the director of the FDA's Center for Drug …

Source: ETPharma.com - Pending
Published on May 13, 2026

Peanut Allergy Treatment Market: Trends, Forecast, and Strategic Insights (2026–2033)

The peanut allergy treatment market is growing rapidly, driven by rising prevalence, advanced therapies, and expanding access to diagnosis and care. LONDON, UNITED KINGDOM, May 13, 2026 /⁨EINPresswire.com⁩/ -- The global peanut allergy treatment …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on May 6, 2026

Sanofi asks to pull diabetes drug out of FDA voucher program, STAT News reports

May 6 (Reuters) – Sanofi has asked the U.S. Food and Drug Administration to pull its diabetes drug out of the regulator’s new fast-track review program, STAT News reported on Wednesday. The move comes after the director of ‌the FDA’s Center for Drug …

Source: KELO - South Dakota - Pending
Published on May 6, 2026

STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review

WASHINGTON — Sanofi has asked the Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of Commissioner Marty Makary’s new speedy drug review program. The move comes after acting Center for Drug Evaluation and Research Director …

Source: STAT - Massachusetts - Neutral
Published on May 5, 2026

Sanofi expands AI capabilities, investing $294M to scale Toronto hub

Sanofi is supercharging its artificial intelligence capabilities. The French pharma is investing $294 million to expand its global AI center of excellence in Toronto, kicking off a scale-up of the digital infrastructure it built at the Canadian hub four …

Source: Fierce Biotech - Neutral
Published on May 12, 2026

IgA Nephropathy: Advances Drive a Wave of New Therapies

New Orleans — New understanding about the pathophysiology of immunoglobulin A nephropathy (IgAN) and a two-phase approval pathway have led to a recent dramatic rise in the number of new therapies for treating the condition. “IgA nephropathy is not a …

Source: Medscape - Neutral
Published on May 4, 2026

Chinese insulin breaks into US market as new drug secures FDA approval

Chinese pharmaceutical company Sunshine Lake Pharma has become the first Chinese firm to win US Food and Drug Administration (FDA) approval for a long-acting insulin product, marking a milestone for the country's biopharmaceutical industry. The company …

Source: CGTN - Gov't Propaganda

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Published on May 13, 2026 - 13:30 GMT

Music Industry Leaders Launch Joint Venture to Build America’s Next Great Music City, Addressing Affordability Crisis

Street Flavor Records and SPNDAT Entertainment announce joint venture with industry insiders to develop a sustainable music city for artists facing crisis. VENICE, FL, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Independent music …

Distribution channels: Music Industry ...
Published on May 13, 2026 - 22:45 GMT

Copa Holdings Reports First-Quarter Financial Results

PANAMA CITY, May 13, 2026 (GLOBE NEWSWIRE) -- Copa Holdings1, S.A. (NYSE: CPA), today announced financial results for the first quarter of 2026 (1Q26), reflecting continued industry-leading profitability, disciplined execution, and the resilience of its …

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Published on May 13, 2026 - 22:57 GMT

Aptera Motors Reports First Quarter 2026 Financial Results

Reports Q1 2026 GAAP Net Loss of $10.2 Million Calculates Q1 2026 Adjusted Net Loss of $6.2 Million (Non-GAAP) Secured $17.1 Million in New Capital and Ended Quarter with $17.7 Million in Cash and Cash Equivalents Drove First Five Validation Vehicles Off …

Distribution channels: Automotive Industry, Business & Economy ...
Published on May 13, 2026 - 22:51 GMT

Atlas Energy Reports First Quarter 2026 Financial Results

CALGARY, Alberta, May 13, 2026 (GLOBE NEWSWIRE) -- Atlas Energy Corp. (“Atlas” or the “Company”) (TSXV: ATLE), a TSXV Sandbox issuer, is pleased to announce its financial and operating results for the three months ended March 31, 2026. Selected financial …

Distribution channels: Business & Economy, Energy Industry ...

Published on May 13, 2026 - 22:00 GMT

Carbon Streaming Announces Financial Results for the Three Months Ended March 31, 2026

TORONTO, May 13, 2026 (GLOBE NEWSWIRE) -- Carbon Streaming Corporation (Cboe CA: NETZ) (OTCID: OFSTF) (FSE: M2Q) (“Carbon Streaming” or the “Company”) today reported its financial results for the three months ended March 31, 2026. All figures are expressed …

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Published on May 13, 2026 - 20:15 GMT

Okeanis Eco Tankers Corp. Reports Financial Results for the First Quarter of 2026

ATHENS, Greece, May 13, 2026 (GLOBE NEWSWIRE) -- Okeanis Eco Tankers Corp. (together with its subsidiaries, unless context otherwise dictates, “OET” or the “Company”) (NYSE: ECO, OSE: OET) today reported its unaudited condensed financial results for the …

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Published on May 13, 2026 - 20:10 GMT

Motorsport Games Reports First Quarter 2026 Financial Results

MIRAMAR, Fla., May 13, 2026 (GLOBE NEWSWIRE) -- Motorsport Games Inc. (NASDAQ: MSGM) (“Motorsport Games” or “the Company”) today reported financial results for its first quarter ended March 31, 2026. The Company has also posted the first quarter 2026 …

Distribution channels: Automotive Industry, Business & Economy ...
Published on May 13, 2026 - 16:00 GMT

The Brooks Group Named to Selling Power’s Top Sales Training Companies 2026 List

Sales training and development leader recognized 17th time for best-in-class programs that drive revenue growth GREENSBORO, NC, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- The Brooks Group, a leading sales training and development company …

Distribution channels: Building & Construction Industry, Energy Industry ...

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Published on May 13, 2026 - 22:58 GMT

Social Commerce Summit Launch Event Brings Together the Operators Building the Next Era of Social Commerce

The inaugural event in L.A. will bring together leaders across platforms, brands, agencies, creator commerce, and finance to discuss what is driving growth. MANHATTAN BEACH, CA, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- The Social Commerce …

Distribution channels: Companies, Conferences & Trade Fairs ...
Published on May 13, 2026 - 22:54 GMT

Reinhausen Manufacturing Inc. Becomes Reinhausen Inc., Reflecting Expanded Portfolio; Services, Automation Solutions

Name change recognizes company's growth beyond manufacturing to include substation and transformer service, automation systems, and asset management solutions HUMBOLDT, NC, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Reinhausen …

Distribution channels: Companies, Energy Industry ...
Published on May 13, 2026 - 22:38 GMT

Leomhann Enterprises Addresses Frequently Asked Questions as Interest Continues to Grow in 2026

Cleveland-based Leomhann Enterprises addresses common questions about careers, leadership training, and company operations. CLEVELAND, OH, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- As online interest in Leomhann Enterprises continues to …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 22:37 GMT

Movie Reviews and More Co-Host and Interior Designer Howard Wiggins Expands Nashville Billboard Campaign

Internationally recognized interior designer and Movie Reviews and More co-host Howard Wiggins expands his Nashville digital billboard campaign. NASHVILLE, TN, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Movie Reviews and More, the …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 22:36 GMT

Video Plus Print and Video-Brochures.ca Mark Nearly Two Decades of Global Innovation in Interactive Brand Communication

Video Plus Print and Video-Brochures.ca expand global growth with immersive communication tools transforming engagement across industries worldwide. ORLANDO, FL, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- As businesses worldwide continue …

Distribution channels: Automotive Industry, Business & Economy ...
Published on May 13, 2026 - 20:56 GMT

Christ's Mission Online Launching to Provide Free Websites and Web Hosting to Churches in Africa With No Web Presence

Christ's Mission Online is forming a 501(c)(3) nonprofit providing free websites and web hosting to Christian churches in Africa that have no digital presence. LINCOLN, NE, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Christ's …

Distribution channels: Agriculture, Farming & Forestry Industry, Amusement, Gaming & Casino ...
Published on May 13, 2026 - 20:49 GMT

GEMINI NEAR ME® Introduces AI-Powered Emotional Intelligence App for Self-Understanding and Connection

Created by Iryna Wood, the app features a real-time, two-way 24/7 AI pocket counselor supporting self-understanding, self-trust, and meaningful connection. NEW YORK, NY, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- GEMINI NEAR ME® …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 20:36 GMT

Pandion Optimization Alliance Announces Partnership with Talar Medical to Support Podiatry and Specialty Care Providers

The partnership will help podiatry and specialty care providers improve efficiency and access tailored solutions that support growth and patient care. ROCHESTER, NY, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Pandion Optimization Alliance …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on May 13, 2026 - 20:35 GMT

EFCG and MSA Professional Services Launch IMERITUS Pilot to Transform Institutional Knowledge into a Capital Asset

This new collaboration will explore how expert knowledge can be captured, preserved, and scaled across professional services organizations BARABOO, WI AND BOSTON, MA, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- The Environmental Financial …

Distribution channels: Banking, Finance & Investment Industry, Building & Construction Industry ...
Published on May 13, 2026 - 20:08 GMT

CENTRAL TEXAS ANGEL NETWORK CELEBRATES 20 YEARS OF EARLY-STAGE INVESTING IN TEXAS

CTAN is celebrating its 20th year, marking two decades of investing in early-stage companies and helping shape the startup ecosystem across Texas. AUSTIN, TX, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Central Texas Angel Network (CTAN) …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 19:59 GMT

Bellus Academy Receives CAPPS 2026 Excellence in Community Service Award

Bellus Academy, a leader in beauty and wellness education, has been recognized with a CAPPS 2026 Excellence in Community Service Award. CHULA VISTA, CA, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Bellus Academy is proud to announce they …

Distribution channels: Beauty & Hair Care, Companies ...
Published on May 13, 2026 - 19:46 GMT

Building a Stronger Relationship with Your Dog Through Positive Reinforcement Training at Off Leash K9 Albany

Off Leash K9 Albany helps dog owners enhance their relationships with their pets using a positive reinforcement-based approach tailored to each dog’s needs. ALBANY, NY, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Dog owners in Albany, NY, …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on May 13, 2026 - 19:43 GMT

LanceSoft Acquires SynergisticIT, a Provider of High-Impact IT Talent Solutions, an IT ExchangeNet Transaction

LanceSoft acquires SynergisticIT to expand tech talent and SOW capabilities in financial services. IT ExchangeNet advised SynergisticIT in this transaction. ISELIN, NJ, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- LanceSoft, a global leader …

Distribution channels: Banking, Finance & Investment Industry, Companies ...
Published on May 13, 2026 - 19:35 GMT

Best Mobile Security Application for Android in 2026: Why TraceX Guard Leads India’s Cyber Defense

TraceX Guard by TraceX Labs delivers AI-powered Android protection against APK malware, phishing, QR scams, spyware, and banking frauds. BENGALURU, INDIA, May 13, 2026 /⁨EINPresswire.com⁩/ -- As Android-based cyber frauds continue rising across …

Distribution channels: Companies, IT Industry ...
Published on May 13, 2026 - 19:14 GMT

Assisting Hands Home Care Expands Awareness of Personalized In-Home Care Services for Families in Ashburn, Virginia

Assisting Hands Home Care provides home care in Ashburn, including companion care, personal care, dementia care, live-in care, and 24-hour support. ASHBURN, VA, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Assisting Hands Home Care, a …

Distribution channels: Beauty & Hair Care, Companies ...
Published on May 13, 2026 - 18:45 GMT

Upfront Plumbing Drains Heating and Air Receives 2026 Quality Business Award for Best Plumbing in Midvale, Utah

MIDVALE, UT, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- The Quality Business Awards has recognized Upfront Plumbing Drains Heating and Air as the recipient of the 2026 Quality Business Award for Best Plumbing in Midvale, Utah. Upfront …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on May 13, 2026 - 18:40 GMT

Bin There Dump That Expands Dumpster Rental Services Across Erie and Northwest Pennsylvania

Bin There Dump That, known for its clean equipment & customer service, now offers service in Erie, Pennsylvania and the greater Northwest Pennsylvania region. ERIE, PA, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Bin There Dump That …

Distribution channels: Building & Construction Industry, Companies ...
Published on May 13, 2026 - 18:24 GMT

Best Cybersecurity Companies in India 2026: Top 10 Industry Leaders

India’s cybersecurity industry is evolving rapidly, with TraceX Labs emerging as a leader in AI-powered threat intelligence and mobile security. NEW YORK, TX, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Cybersecurity has become one of the …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 18:05 GMT

Small Businesses Are Investing More in AI While Maintaining a Professional Presence Thanks to Opus Virtual Offices

As AI adoption accelerates among small businesses, Opus Virtual Offices eliminates the overhead costs that hold entrepreneurs back. BOCA RATON, FL, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Artificial intelligence has moved from buzzword …

Distribution channels: Business & Economy, Companies ...
Published on May 13, 2026 - 18:03 GMT

Dunlap Bennett & Ludwig Ranked in the 2026 WTR 1000 Among the World’s Leading Trademark Professionals

WASHINGTON, DC, UNITED STATES, May 13, 2026 /⁨EINPresswire.com⁩/ -- Dunlap Bennett & Ludwig (DBL), a veteran-owned law firm, is proud to share that it has earned a place in the 2026 edition of the World Trademark Review (WTR) 1000. Now in …

Distribution channels: Business & Economy, Companies ...