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Tag: drug application

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

HYDERABAD, India, August 1, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final approval from the U.S....

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

HYDERABAD, India, July 31, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final approval from the U.S....

RECORDATI: STRONG MOMENTUM OF THE GROUP CONTINUES IN THE FIRST HALF OF 2025 REVENUE +11.7%, EBITDA(1) +9.6%, ADJUSTED NET INCOME(2) +8.9%

Milan, 29th July 2025 – The Board of Directors of Recordati S.p.A. approved the interim financial statements as of June 30, 2025, pursuant to Art. 154-ter of Italian Legislative Decree 58/1998 and subsequent amendments, prepared in accordance with said Decree and the CONSOB Issuers Regulation. The statements were prepared in accordance with International Accounting Standard (IAS) 34 requirements for interim reporting, based on the assessment, measurement and recognition criteria set by the IFRSs. The interim financial statements on June 30, 2025 – as well as the Independent Auditors’ report on such statements - will be available within the legal deadline at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info(www.1Info.it).

UROGEN FINAL DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors in to...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

Everest Medicines Announces Share Placement to Raise Approximately HK$1,572.50 Million

SHANGHAI, July 25, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest" or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and...

Telix Reports $204M Revenue, Up 63% YOY

MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise.

UROGEN DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds UroGen Pharma (URGN) Investors of the July 28th Deadline and Urges Investors to Inquire About...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

UROGEN ALERT: Bragar Eagel & Squire, P.C. Urges Investors in UroGen Pharma (URGN) to Inquire About Their Rights in Class Action Lawsuit

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /PRNewswire/ -- As lawmakers weigh potential cuts to scientific research...

Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /PRNewswire/ -- As lawmakers weigh potential cuts to scientific research...

Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /CNW/ -- As lawmakers weigh potential cuts to scientific research...

Menin Inhibitors Market Forecasts Signal Strong Uptake of Menin Inhibitors in Hematologic Oncology Across the 7MM During the Forecast Period (2020-2034) | DelveInsight

The menin inhibitor market is poised for rapid growth, with REVUFORJ setting the foundation and a strong pipeline of innovative, genetically targeted therapies on...

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