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Aug 31, 2026, 07:30 ET Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis
commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking Accelerated Approval for XPOVIO® (selinexor) in combination with ruxolitinib for patients with myelofibrosis.
More news about: Karyopharm Therapeutics Inc.
Aug 31, 2026, 07:29 ET "The 'I Choose…' Framework" Helps Readers Shift From Passive Subconscious Habits to Active, Intentional Decisions by Utilizing Three Core Tools
impact long-term physical and emotional quality of life. Drawing from his own personal journey, including surviving a teenage suicide attempt, overcoming drug abuse, serving in the U.S. Army and retiring from corporate America at age 47, Sterner combines memoir storytelling with practical behavioral exercises.Sterner
More news about: Balboa Press
Aug 31, 2026, 07:00 ET Labcorp Launches Next Generation of Labcorp Global Trial Connect™ to Help Sponsors and Investigator Sites Navigate Clinical Trial Complexity
clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 71,000 employees serve clients in approximately 100 countries, provided support for more than
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Aug 31, 2026, 07:00 ET New Phase 3b data on Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) used together showed improved and durable efficacy at one year in adults with psoriatic disease and obesity
Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results
More news about: Eli Lilly and Company
Aug 31, 2026, 06:45 ET Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases
However, as with any such undertaking, there are substantial risks and uncertainties in closing and implementing the acquisition and in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will close the transaction or realize the expected
More news about: Eli Lilly and Company
Aug 31, 2026, 06:05 ET Karmanos Now Offers FDA-Approved Daraxonrasib (Rasonque) for Metastatic Pancreatic Cancer
approval by the U.S. Food and Drug Administration (FDA) on Aug. 26, 2026. Karmanos was one of the institutions worldwide that contributed to FDA approval by conducting the RASolute 302
More news about: Karmanos Cancer Institute
Aug 31, 2026, 06:00 ET IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer
integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class
More news about: IDEAYA Biosciences, Inc.
Aug 31, 2026, 06:00 ET Ziihera® (zanidatamab-hrii) plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Versus Trastuzumab plus Chemotherapy in First-Line HER2+ Advanced GEA
standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal
More news about: Jazz Pharmaceuticals plc
Aug 31, 2026, 05:37 ET Fosun International Holds 2026 Interim Results Presentation: Unlocking Core Pathways, Accelerating Growth in Industries where we Excel
decade of effort, it has established technology platforms covering monoclonal antibodies, bispecific antibodies, multispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, small molecules, autologous CAR-T, next-generation universal CAR-T, and radiopharmaceuticals. It has also built
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Aug 31, 2026, 03:30 ET Capricor Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - CAPR
data for Deramiocel. The Company failed to secure the FDA's agreement to this change before it resubmitted a Biologics License Application for the drug. Based on these facts, Capricor's public statements were false and materially misleading throughout the class period.If you are a shareholder
More news about: DJS Law Group LLP
Aug 31, 2026, 03:18 ET AMGEN'S REPATHA® REDUCES RISK OF DEATH IN PATIENTS AT HIGH RISK FOR A FIRST HEART ATTACK OR STROKE
Sodium content: Repatha contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium-free'.Interactions: No formal drug-drug interaction studies have been conducted for Repatha. No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering
More news about: Amgen
Aug 31, 2026, 02:00 ET BioMarin Announces Global Settlement with Ascendis Pharma A/S; Ascendis Will Pay Royalties to BioMarin on Yuviwel Sales in U.S., EU, Brazil and South Korea
a proven track record of innovation, with nine commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound
More news about: BioMarin Pharmaceutical Inc.
Aug 31, 2026, 01:00 ET Samsung Biologics publishes prospectus for PolyPeptide public tender offer
Biologics leverages cutting-edge technologies and expertise to advance diverse modalities, including multispecific antibodies, fusion proteins, antibody-drug conjugates, and mRNA therapeutics.By implementing the ExellenS™ framework across its manufacturing network with standardized designs, unified
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Aug 30, 2026, 20:00 ET WuXi AppTec Continues to Reward Shareholders, Further Increasing Interim Dividend to RMB 1.51 Billion
work alongside partners across 30+ countries, supporting their efforts to bring breakthrough treatments to patients. Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at
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Aug 30, 2026, 06:15 ET Ascletis Announces First Participant Dosed in a Global Phase III Clinical Program of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 for Chronic Weight Management
(AURORA-2).- Topline data from the AURORA Phase III clinical program are expected in the third quarter of 2028, with a U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission expected by the end of 2028 and European Medicines Agency (EMA) Marketing Authorisation Application (MAA)
More news about: Ascletis Pharma Inc.
Aug 30, 2026, 06:15 ET 歌禮宣布每日一次口服小分子GLP-1受體激動劑ASC30用於長期體重管理的全球III期臨床項目完成首例受試者給藥
一家全價值鏈整合型生物技術公司，聚焦有望成為治療代謝疾病同類最佳（best-in-class）和同類首創（first-in-class）藥物的開發和商業化。利用公司專有的基於結構的AI輔助藥物發現（Artificial Intelligence-assisted Structure-Based Drug Discovery，AISBDD）、超長效藥物開發平台（Ultra-Long-Acting Platform，ULAP）技術以及口服多肽遞送增強技術（Peptide Oral Transport ENhancement Technology，POTENT），歌禮已自主研發多款小分子和多肽候選藥
More news about: 歌禮製藥有限公司
Aug 28, 2026, 22:00 ET Capricor Therapeutics, Inc. Notice of September 28, 2026 Application Deadline for Class Action Lawsuit - Contact Lewis Kahn, Esq. at Kahn Swick & Foti, LLC, Before Application Deadline
to disclose material information during the Class Period, violating federal securities laws. On July 27, 2026, pre-market, the U.S. Food and Drug Administration ("FDA") published briefing documents ahead of its July 29 advisory committee meeting to review the Biologics License Application ("BLA")
More news about: Kahn Swick & Foti, LLC
Aug 28, 2026, 17:42 ET Robbins LLP Urges AARD Stockholders Who Lost Money Investing in Aardvark Therapeutics, Inc. to Contact the Firm for Information About Leading the Class Action
2, 2026.Then, on May 14, 2026, Aardvark issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company's previously announced voluntary pause." The press release
More news about: Robbins LLP
Aug 28, 2026, 16:15 ET Nektar Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166 and NKTR-422 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings
More news about: Nektar Therapeutics
Aug 28, 2026, 15:02 ET U.S. Food and Drug Administration Authorizes Juul Labs' Next Generation JUUL2 System
smoke WASHINGTON, Aug. 28, 2026 /PRNewswire/ -- Yesterday, the U.S. Food and Drug Administration issued marketing granted orders for Juul Labs' next generation JUUL2 System with tobacco- and menthol-flavored pods. Juul Labs submitted
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Aug 28, 2026, 14:52 ET APhA Foundation Announces 2026 Pinnacle Award Recipients
collaboration across the health care team. Honorees are selected for work that advances key outcomes, including increased medication adherence, reduced adverse drug events, greater use of national treatment guidelines, improved patient outcomes, and enhanced communication among health care professionals."We
More news about: American Pharmacists Association Foundation
Aug 28, 2026, 13:52 ET ByHeart Update: FDA Confirms Review of ByHeart's Root Cause Investigation and Action Plan, Following Completion of Facility Inspections
November 2025 infant botulism outbreak and its work toward a responsible return to infant formula production. ByHeart provided the U.S. Food and Drug Administration with an approximately 400-page comprehensive submission detailing the company's root cause investigation findings, assessments conducted
More news about: ByHeart
Aug 28, 2026, 12:58 ET Tampa General Hospital and Florida Orthopaedic Institute First in World to Use New EVOS Pelvic and Acetabular System
president and chief medical officer of Florida Orthopaedic Institute.The EVOS Pelvic and Acetabular System received clearance from the U.S. Food and Drug Administration (FDA) in February 2025 for the fixation of fractures and disruptions of the pelvis and acetabulum — the socket portion of the hip joint
More news about: Tampa General Hospital
Aug 28, 2026, 12:53 ET Hagens Berman Alerts Capricor Therapeutics, Inc. (NASDAQ: CAPR) Investors to FDA Review Extension for Deramiocel Amid Ongoing Securities Class Action and September 28 Lead Plaintiff Deadline
CAPR) of the upcoming September 28, 2026 lead plaintiff deadline in the ongoing securities class action. This alert follows the U.S. Food and Drug Administration's (FDA) recent decision to extend the review period for Capricor's Biologics License Application (BLA), underscoring the ongoing regulatory
More news about: Hagens Berman Sobol Shapiro LLP
Aug 28, 2026, 12:26 ET Aardvark Therapeutics (AARD) Investors: Securities Fraud Class Action Filed, Contact Hagens Berman Before October 13, 2026 Lead Plaintiff Deadline
stock price plummeted over 56%. May 14, 2026: Aardvark announced that the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its investigational new drug application (IND) for ARD-101, halting all ongoing studies under the IND, including the Phase 3 HERO trial and
More news about: Hagens Berman Sobol Shapiro LLP