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DUBLIN--(BUSINESS WIRE)--The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ResearchAndMarkets.com's offering. The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that yo...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new long-term data reinforcing the safety and efficacy profile of Livdelzi® (seladelpar) for people living with primary biliary cholangitis (PBC). Findings support Livdelzi's consistent efficacy and safety outcomes in patients switching from obeticholic acid and positive impact on liver stiffness over 3 years. These findings were presented at The Liver Meeting® hosted by the American Association for the S...

RALEIGH, Carolina do Norte--(BUSINESS WIRE)--A Merz Aesthetics, a maior empresa do mundo dedicada à estética médica, anunciou hoje a aprovação do Ultherapy PRIME pela Food and Drug Administration (FDA) dos EUA para melhorar a aparência da flacidez da pele na parte anterior e posterior dos braços e no abdômen. O Ultherapy PRIME é a única solução aprovada pela FDA com visualização em tempo real para tratar o rosto**, pescoço, colo e agora o corpo*.1 As novas indicações serão lançadas nos EUA ante...

RALEIGH, Carolina del Norte--(BUSINESS WIRE)--Merz Aesthetics, la empresa dedicada a la estética médica más grande del mundo, anunció hoy que la Administración de Alimentos y Medicamentos (FDA) de los Estados Unidos aprobó Ultherapy PRIME para mejorar la apariencia de la flacidez cutánea en la parte anterior y posterior de los brazos y en el abdomen. Ultherapy PRIME es la única solución aprobada por la FDA con visualización en tiempo real para tratar el rostro**, el cuello, el escote y ahora ta...

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States. The product is being recalled due to out-of-specification (OOS) endotoxin results of certain rese...

CRANBURY, N.J.--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and recent operational results for the third quarter ending September 30, 2025. “During the third quarter, we maintained disciplined execution and sharpened our strategic focus on Rocket’s AAV cardiovascular gene therapy portfolio,” said Gaurav Sha...

NEW YORK--(BUSINESS WIRE)--Flatiron Health today announced its presence at the European Society For Medical Oncology AI & Digital Oncology Congress 2025 (ESMO AI) taking place on November 12-14 in Berlin, Germany. Flatiron’s experts will be presenting five pieces of research, in addition to leading the speaking session, “The VALID Framework for LLM-Extracted Oncology Data Quality: Comprehensive methodology for evaluating LLM-extracted real-world oncology data quality.” “Our research present...

ノースカロライナ州ローリー--(BUSINESS WIRE)--（ビジネスワイヤ） -- 世界最大の医療美容専門企業であるメルツ・エステティックス（Merz Aesthetics）は、米国食品医薬品局（FDA）が「ウルセラピー・プライム（Ultherapy PRIME）」を上腕前部、上腕後部および腹部の皮膚のたるみ改善に対して認可したことを発表しました。 ウルセラピー・プライムは、顔**、首、デコルテに加え、今回新たに身体*にも対応する、リアルタイム可視化機能を備えた唯一のFDA認可済みソリューションです。1これらの新たな適応は、まず米国で発売され、その後、世界各国の市場へと展開される予定です。 「今回のFDA認可は、昨年のウルセラピー・プライムの成功に続く、当社の著しい成長の証しです」と、メルツ・エステティックスの最高経営責任者（CEO）ボブ・ラティガンは述べています。「顔**から身体*へと治療領域を拡大することで、新たな施術の可能性を広げ、高まる患者ニーズに応えるとともに、非侵襲的スキンリフティングおよび引き締め分野におけるリーダーシップをさらに強化しています。」 ウルセラピー・...

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced new long-term data for DAWNZERA™ (donidalorsen), the first and only RNA-targeted prophylactic medicine for hereditary angioedema (HAE), to be presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida. Results demonstrate the long-term durability and safety of DAWNZERA, including new data from patients who were followed for one year...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced new real-world data published in Current Medical Research and Opinion finding that the Shield blood-based screening test demonstrates patient adherence of 95% in screening for colorectal cancer (CRC). Shield is the first and only blood test to receive FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. In the analysi...