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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old

BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency.

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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients as Young as 2 Years Old

Renovaro Regains Compliance with NASDAQ Listing Requirement

LOS ANGELES, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, today announced that it has received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule, 5550(a)(2). The Company’s security will continue to be listed and traded on The Nasdaq Stock Market and this matter is now closed.

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Renovaro Regains Compliance with NASDAQ Listing Requirement

Teva to Host Conference Call to Discuss Fourth Quarter and Full Year 2024 Financial Results and 2025 Financial Guidance at 8 a.m. ET on January 29,…

TEL AVIV, Israel, Dec. 20, 2024 (GLOBE NEWSWIRE) --  Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its fourth quarter and full year 2024 financial results, as well as on its financial guidance for 2025, on Wednesday, January 29, 2025, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET.

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Teva to Host Conference Call to Discuss Fourth Quarter and Full Year 2024 Financial Results and 2025 Financial Guidance at 8 a.m. ET on January 29,...

Procaps Group Announces Key Shareholder and Board Decisions, Committee Restructuring, and Leadership Updates

MIAMI and BARRANQUILLA, Colombia, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced significant outcomes from its recent Shareholders Meeting and subsequent Board of Directors meeting. These include changes to the Board composition, restructuring of Board committees, and updates to its executive leadership team.

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Procaps Group Announces Key Shareholder and Board Decisions, Committee Restructuring, and Leadership Updates

PharmAla Issues Audited Financial Statements, Completes Continuance to Ontario, and Closes Private Placement

TORONTO, Dec. 20, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce its financial and operational results for the year ended August 31, 2024, the highlights of which are included in this news release. All figures are reported in Canadian dollars. The Company’s full set of consolidated audited financial statements for the years ended August 31, 2024 and 2023 and accompanying management’s discussion and analysis can be accessed by visiting the Company’s website at www.PharmAla.ca and its profile page on SEDAR+ at www.sedarplus.ca.

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PharmAla Issues Audited Financial Statements, Completes Continuance to Ontario, and Closes Private Placement

Spectral AI Highlights Unprecedented Collaboration with National Leaders in Burn Care for DeepView™ System Training and Validation Studies

DALLAS, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced that national leaders in burn care have dedicated more than an estimated 511 in-person days of physician engagement to the training and validation studies for the DeepView™ System for U.S. Food and Drug Administration (FDA) submission. This does not include more than an estimated 250 additional days that these experts devoted in Proof-of-Concept studies.

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Spectral AI Highlights Unprecedented Collaboration with National Leaders in Burn Care for DeepView™ System Training and Validation Studies