Search Results
Dec 05, 2025, 08:00 ET Blueprint Medicines, a Sanofi Company, Highlights Long-Term Clinical Benefit of AYVAKIT® (avapritinib) Across Indolent and Advanced Systemic Mastocytosis at 2025 ASH Annual Meeting
www.fda.gov/medwatch.AYVAKIT is available in 25-mg, 50-mg, 100-mg and 200-mg tablets.Please click here to see the full
More news about: Blueprint Medicines, a Sanofi company
Dec 05, 2025, 08:00 ET Astellas To Present New Data on XOSPATA™ (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting
XOSPATA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids
More news about: Astellas Pharma Inc.
Dec 05, 2025, 06:12 ET November in Review: 10 Top Health Press Releases
GLP-1 Induced Nausea and VomitingThis study, which pre-treated patients with either tradipitant or placebo before administering a 1 mg injection of Wegovy®, a dose that normally takes 9 weeks of titration to reach, succeeded and met its primary endpoint, with only 29.3% of tradipitant-treated
More news about: PR Newswire
Dec 04, 2025, 10:56 ET INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of aTyr Pharma
corticosteroid (OCS) dose at week 48, with the OCS dose reducing by an average of 2.79mg for 5.0 mg/kg efzofitimod compared to 3.52 mg for placebo. Complete steroid withdrawal was achieved for 52.6% of patients treated with 5.0 mg/kg efzofitimod versus 40.2% on placebo.After aTyr Pharma released the results,
More news about: Faruqi & Faruqi, LLP
Dec 04, 2025, 08:52 ET Celt Salt Introduces HydroCelt Clean Hydration Electrolyte Drink Mix
two delicious flavors, Citrus Splash and Peachy Twist, HydroCelt is powered by 600 mg of unrefined Celt Salt, delivering 80+ trace minerals, and is paired with 250 mg potassium citrate and 90 mg magnesium glycinate (two of the most easily absorbed and stomach-friendly forms of electrolytes).With
More news about: Celt Salt
Dec 04, 2025, 08:12 ET UCB shares leading scientific research and advances at American Epilepsy Society Annual Meeting
dosage of FINTEPLA is 17 mg.Coadministration of FINTEPLA with stiripentol plus clobazam, with or without valproate, increases fenfluramine plasma concentrations. If FINTEPLA is coadministered with stiripentol plus clobazam, the maximum daily dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum
More news about: UCB
Dec 04, 2025, 08:00 ET Atossa Therapeutics Details Accelerated FDA Strategy to Advance (Z)-Endoxifen Across Breast Cancer Continuum
in both healthy women and those with breast cancer. In nearly 800 adults (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.Atossa's (Z)-endoxifen program is supported
More news about: Atossa Therapeutics Inc
Dec 04, 2025, 07:08 ET Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development
no drug-related serious adverse events reported. Specifically, at the end of the treatment, the least-square-mean dysmenorrhea pain score in the 240 mg every two weeks (q2w) dose group decreased by 42% from baseline, and the non-menstrual chronic pelvic pain score decreased by 52%, both with statistical
More news about: Hope Medicine
Dec 04, 2025, 07:00 ET Novo Nordisk solicita aprovação da FDA para Wegovy® 7,2 mg, dose mais alta do medicamento
versus 16,7% com semaglutida 2,4 mg e 0,0% com placebo. Considerando também quem descontinuou o tratamento, a perda de peso com semaglutida 7,2 mg foi de 18,7%, frente a 15,6% com a dose de 2,4 mg e 3,9% com placebo. No total, 90,7% dos participantes que receberam 7,2 mg perderam pelo menos 5% do peso
More news about: Novo Nordisk
Dec 04, 2025, 02:18 ET New Leqembi-data presented at CTAD 2025 suggests potential to delay disease progression by up to 8.3 years with continued treatment
the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%).Based on clinical data
More news about: BioArctic
Dec 04, 2025, 02:13 ET New Leqembi-data presented at CTAD 2025 suggests potential to delay disease progression by up to 8.3 years with continued treatment
the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%).Based on clinical data
More news about: BioArctic
Dec 03, 2025, 19:00 ET Argentina Lithium & Energy Corp. Files Technical Report for the Rincon West Lithium Project
71.6Concentration (mg/l) 297
More news about: Argentina Lithium & Energy Corp.
Dec 03, 2025, 18:10 ET Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer's Disease at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025
the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%).Based on clinical data
More news about: Eisai Inc.
Dec 03, 2025, 12:59 ET U.S. FDA approves expanded indication for Lilly's Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor
lymphoma (MCL) and chronic lymphocytic leukemia (CLL).3,4 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.About Chronic Lymphocytic Leukemia/Small
More news about: Eli Lilly and Company
Dec 03, 2025, 09:14 ET Amid Rising Screen Time and Lifestyle Stress, New Survey Reveals 3 in 4 Americans Battle Dry Eye Symptoms Weekly
blend of OxyLytes™, the five vital electrolytes (Sodium Na+, Potassium K+, Calcium Ca2+, Magnesium Mg2+, Bicarbonate HCO3-) found in natural tears. The EXTRA formula offers up to 12 hours of hydrating comfort. Available
More news about: TheraTears®
Dec 02, 2025, 19:43 ET Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®
U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR® (omalizumab). OMLYCLO 75 mg/0.5 mL, 150 mg/mL and 300 mg/2mL solutions in a single-dose prefilled syringe is approved as interchangeable with the reference product for all indications based on
More news about: Celltrion
Dec 02, 2025, 18:16 ET Accord Healthcare annonce le lancement de son deuxième biosimilaire du denosumab dans le domaine de la santé osseuse
importants.Soutenir les cliniciens et les systèmes de santé dans le domaine de la santé osseuseOsvyrti (denosumab), disponible en seringue préremplie de 60 mg, est indiqué pour1 :Le traitement de l'ostéoporose chez les femmes ménopausées et les hommes présentant un risque accru
More news about: Accord Healthcare
Dec 02, 2025, 18:11 ET Accord Healthcare kündigt Einführung von Denosumab∇ an - zweites Biosimilar im Bereich Knochengesundheit
aus.Unterstützung von Klinikern und Gesundheitssystemen bei der KnochengesundheitOsvyrti (Denosumab), das als Fertigspritze zu 60 mg erhältlich ist, ist indiziert für1:die Behandlung von Osteoporose bei Frauen nach den Wechseljahren und bei Männern
More news about: Accord Healthcare
Dec 02, 2025, 18:00 ET Accord Healthcare anuncia el lanzamiento de Denosumab∇, el segundo biosimilar para la salud ósea
clínica.Apoyando a los profesionales sanitarios y a los sistemas de salud en la salud óseaOsvyrti (denosumab), disponible en jeringa precargada de 60 mg, está indicado para1:El tratamiento de la osteoporosis en mujeres posmenopáusicas y en hombres con mayor riesgo de
More news about: Accord Healthcare
Dec 02, 2025, 17:53 ET Accord Healthcare anuncia o lançamento do Denosumabe∇ - Segundo Biossimilar em Saúde Óssea
necessidade clínica.Apoio a médicos e sistemas de saúde na saúde ósseaOsvyrti (denosumabe) disponível como uma seringa pré-carregada de 60 mg é indicado para1:O tratamento da osteoporose em mulheres na pós-menopausa e em homens com maior risco de fraturas.O
More news about: Accord Healthcare
Dec 02, 2025, 17:50 ET Accord Healthcare anuncia el lanzamiento de Denosumab∇, segundo biosimilar en salud ósea
clínica.Apoyo a los médicos y sistemas sanitarios en salud óseaOsvyrti (denosumab) está disponible como jeringa precargada de 60 mg y está indicado para1:El tratamiento de osteoporosis en mujeres posmenopáusicas y en hombres con mayor riesgo de fracturas.El
More news about: Accord Healthcare
Dec 02, 2025, 17:45 ET 어코드 헬스케어, 두 번째 골다공증 바이오시밀러 제품인 데노수맙 출시
및 의료 체계 지원60mg 완제 주사기 형태로 출시되는 오스비르티(데노수맙 계열)는 다음과 같은 용도로 승인받았다1.골절 위험이 큰 폐경 후 여성과 남성의 골다공증 치료골절 위험이 큰 전립선암 남성 환자가 호르몬 박탈 요법으로 인해 유발된 골 소실 치료골절 위험이 큰 성인 환자가 장기간 받은 전신 글루코코르티코이드 요법으로 인해 유발된 골 소실 치료120mg 바이알 제형으로 출시되는 주베렉(데노수맙
More news about: Accord Healthcare
Dec 02, 2025, 16:40 ET New Data Presented at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025 Confirms Pharmacological Effect of LEQEMBI® (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CSF
moderate in severity)LEQEMBI (lecanemab-irmb) is available:Intravenous infusion: 100 mg/mLSubcutaneous injection: 200 mg/mLPlease see full
More news about: Eisai Inc.
Dec 02, 2025, 09:00 ET Vaderis Therapeutics Announces The New England Journal of Medicine Publishes Engasertib Proof-of-Concept and Long-Term Extension Results, Highlighting the Therapy's Potential for Patients with Hereditary Hemorrhagic Telangiectasia
enrolled 75 adults with moderate-to-severe HHT across the United States and European sites. Participants were randomized to receive oral engasertib (30 mg, 40 mg) or placebo for 12 weeks, followed by a long-term open-label extension. (ClinicalTrials.gov Identifier: NCT05406362)Primary
More news about: Vaderis Therapeutics AG
Dec 02, 2025, 09:00 ET Vaderis Therapeutics Announces The New England Journal of Medicine Publishes Engasertib Proof-of-Concept and Long-Term Extension Results, Highlighting the Therapy's Potential for Patients with Hereditary Hemorrhagic Telangiectasia
enrolled 75 adults with moderate-to-severe HHT across the United States and European sites. Participants were randomized to receive oral engasertib (30 mg, 40 mg) or placebo for 12 weeks, followed by a long-term open-label extension. (ClinicalTrials.gov Identifier: NCT05406362)Primary
More news about: Vaderis Therapeutics AG