NEW YORK, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Ultragenyx Pharmaceutical Inc. ("Ultragenyx" or the "Company") (NASDAQ: RARE) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Ultragenyx investors who were adversely affected by alleged securities fraud between August 3, 2023 and December 26, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/ultrag ...

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith reminds investors of the upcoming April 7, 2026 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased Inovio Pharmaceuticals, Inc. ("Inovio†or the "Company†) (NASDAQ: INO) securities between October 10, 2023 and December 26, 2025, inclusive (the "Class Period†). IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN INOVIO PHARMACEUTICALS, INC. (INO), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PA. ...

Core Insights - The FDA is planning to phase out petroleum-based synthetic dyes in food, indicating a shift towards safer food additives [1] - The FDA is addressing concerns over the mass compounding of GLP-1 drugs, particularly in relation to telehealth companies like Hims & Hers [4][6] - The FDA's recent decision to review Moderna's mRNA flu shot application reflects ongoing regulatory challenges and industry concerns about consistency [7][9] Group 1: FDA's Regulatory Actions - The FDA is serious about cracking down on unlawful mass compounding of GLP-1s, citing quality and safety concerns [4] - The agency plans to restrict GLP-1 ingredients in non-approved compounded drugs, emphasizing compliance with federal law [4] - FDA Commissioner Makary expressed hope that illegal mass compounding of GLP-1s could end by 2026, contingent on compliance from manufacturers [6] Group 2: Moderna's Flu Shot Application - The FDA has reversed its earlier decision and will review Moderna's application for an experimental mRNA flu shot, with a decision expected by August 5 [7] - Makary stated that the FDA's guidance to Moderna was clear regarding trial design, particularly for older adult participants [8] - Moderna has contested the FDA's requirements for trial comparators, arguing that they are inconsistent with prior communications [9] Group 3: U.S. Drug Development Landscape - Makary warned that the U.S. is falling behind China in early-stage drug development, highlighting the need for reforms to streamline clinical trial processes [10][11] - He identified key bottlenecks in the drug development process, including hospital contracting and ethics reviews, which hinder competitiveness [12] - The FDA is exploring partnerships with health systems and academic centers to expedite the pre-IND process, aiming to enhance domestic innovation [13]

Johnson & Johnson on Wednesday announced plans to invest more than $1 billion in a next-generation manufacturing facility that will produce advanced cell therapy technologies. The facility will be located in Montgomery County, Pennsylvania, and Johnson & Johnson said the move will expand its U.S. manufacturing capacity along with its pipeline of transformational medicines for cancer, immune-mediated and neurological diseases.Johnson & Johnson added that the facility will have cutting-edge manufacturing proc ...

PresentationMakoto InouePresident, CEO & Representative Director Thank you for taking time to join Otsuka Holdings financial results briefing today. I am Inoue, President and CEO. Before getting into the details of our FY 2025 financial results, I would like to begin by sharing our mid- to long-term strategies. It has now been about 1 year since I assumed the role of President. During this time, we have made several important decisions ranging from research and development initiatives to asset acquisitions ...

Eli Lilly and Co. (NYSE:LLY) on Monday shared positive topline results from the Phase 3 LIBRETTO-432 clinical trial for Retevmo (selpercatinib). The trial demonstrated a highly statistically significant improvement in event-free survival for patients with early-stage non-small cell lung cancer. Lung Cancer Trial Shows Benefit The LIBRETTO-432 trial results showed that selpercatinib significantly reduced the risk of disease recurrence or death in patients with RET fusion-positive non-small cell lung cance ...

Key Takeaways BHC shares fell after Q4 EPS missed estimates despite 9% revenue growth and a top-line beat.BHC's Salix and International units drove gains, with Xifaxan sales up 10% year over year.BHC guided 2026 revenues to $10.625-$10.875B, above consensus expectations.Bausch Health Companies Inc. (BHC) reported mixed results for the fourth quarter of 2025. Consequently, shares are trading down in after-hours trading.Adjusted earnings per share (EPS) of $1.08 missed the Zacks Consensus Estimate of $1.21 bu ...

BOSTON--(BUSINESS WIRE)--PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone in IPF. ...

Industry Overview - The healthcare industry in the United States is a multi-trillion-dollar sector, with spending expected to exceed $5.3 trillion in 2024, representing nearly one-fifth of the U.S. economy [1] Company Analysis: AbbVie - AbbVie is a pharmaceutical giant with a diverse portfolio that includes treatments for immunology, neuroscience, oncology, aesthetics, and eye care [5] - The company has a solid 3% dividend yield and is recognized as a Dividend King, having increased its dividend for at least 50 consecutive years, showcasing its adaptability [6] - AbbVie is entering a new growth phase driven by blockbuster drugs Rinvoq and Skyrizi, with analysts projecting earnings growth of over 17% annually in the long term [6] Company Analysis: Eli Lilly - Eli Lilly is a leader in the obesity drug market, with Morgan Stanley estimating the market could reach $144 billion by the end of the decade [7] - The company has gained market share with its key drug tirzepatide, featured in Mounjaro and Zepbound, outperforming competitor Novo Nordisk [7] - Eli Lilly has a strong pipeline, including an imminent FDA approval for orforglipron, its first oral GLP-1 agonist, and a promising next-generation drug, Retatrutide, which could become a top seller [8] - Wall Street anticipates nearly 25% annualized earnings growth for Eli Lilly over the long term, making it a strong buy-and-hold candidate [8]

Management attributed the exceptional 2025 performance to the 'stunning' early launch of Brinsupri and accelerated global growth of ARIKAYCE, particularly in Japan and Europe. The Brinsupri launch is exceeding internal benchmarks, with $144.6 million in net revenue during its first full quarter, positioning it as potentially the best specialty respiratory launch in history. The strategic focus is on 'owning' the bronchiectasis and NTM categories, leveraging a similar call point among pulmonologists fo ...