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Aug 06, 2026, 21:58 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Replimune Group, Inc. - REPL
joining the class action]On July 28, 2026, the U.S. Food and Drug Administration published briefing documents stating concerns about the data package that Replimune has offered to support accelerated approval for its drug RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's
More news about: Pomerantz LLP
Aug 06, 2026, 19:00 ET Energenesis Biomedical and Taiwan Tanabe Seiyaku Enter Joint Development Agreement for ENERGI-F703DFU
Joint development program to support process technology transfer and chemistry, manufacturing and controls (CMC) preparation for a potential new drug application (NDA) in Taiwan.The parties plan to evaluate subsequent manufacturing and commercialization licensing arrangements in Taiwan and
More news about: Energenesis Biomedical Co., Ltd.
Aug 06, 2026, 18:30 ET Rosen Law Firm Encourages Disc Medicine, Inc. Investors to Inquire About Securities Class Action Investigation - IRON
action.What is this about: On February 13, 2026, the U.S. Food and Drug Administration ("FDA") issued a Complete Response Letter ("CRL") to Disc Medicine regarding its bitopertin program. The FDA stated they could not approve Disc Medicine's new drug application ("NDA") as there were uncertainties in the NDA
More news about: THE ROSEN LAW FIRM, P. A.
Aug 06, 2026, 16:25 ET CytoSorbents Reports Second Quarter 2026 Financial Results, Recent Business Highlights, and Regulatory Update
positive results of the STAR-T trial in CABG patients now published and the growing body of real-world evidence using our therapies for the anti-platelet drug Brilinta® and the direct oral anticoagulants, Eliquis® and Xarelto®, we are confident in the worldwide potential of our technologies for this application.
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Aug 06, 2026, 16:19 ET Erasca, Inc. Deadline: ERAS Investors with Losses in Excess of $100K Have Opportunity to Lead Erasca, Inc. Securities Fraud Lawsuit
its lead oncology drug candidate, ERAS-0015, throughout the Class Period. According to the complaint, Erasca repeatedly touted ERAS-0015 as a potential "best-in-class" therapy and highlighted purportedly superior preclinical results compared to Revolution Medicines' competing drug candidate, RMC-6236,
More news about: THE ROSEN LAW FIRM, P. A.
Aug 06, 2026, 16:05 ET Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2026
ingredient, or API products. Most of the Company's finished products are contracted and distributed through group purchasing organizations, drug wholesalers, and drug retailers. More information and resources are available at www.amphastar.com.Amphastar's
More news about: Amphastar Pharmaceuticals, Inc.
Aug 06, 2026, 16:05 ET MetaVia Reports Second Quarter 2026 Financial Results and Provides Corporate Update
obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose
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Aug 06, 2026, 16:05 ET Cryoport Reports Second Quarter 2026 Financial Results
Biologics License Applications (BLA) / Marketing Authorization Applications (MAA). During the Q2 2026, Cryoport's customer, Orca Bio, received U.S. Food and Drug Administration (FDA) approval for TREGZI™ as the first and only precision-engineered cell therapy for allogeneic stem cell transplant in the treatment
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Aug 06, 2026, 16:03 ET BioMarin Reports Second Quarter 2026 Financial and Operating Results
and Pipeline HighlightsInnovationBioMarin recently submitted its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of VOXZOGO for the treatment of hypochondroplasia. If approved, VOXZOGO would be the first
More news about: BioMarin Pharmaceutical Inc.
Aug 06, 2026, 16:01 ET HALOZYME REPORTS RECORD SECOND QUARTER 2026 RESULTS, BEATS ESTIMATES AND RAISES FULL YEAR 2026 FINANCIAL GUIDANCE
monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms ("MPNs"), utilizing Halozyme's proprietary ENHANZE® drug delivery technology. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE®.
More news about: Halozyme Therapeutics, Inc.
Aug 06, 2026, 16:00 ET Vexev Raises $6M to Accelerate U.S. Commercialization of Autonomous Vascular Imaging Platform
www.vexev.com.Regulatory Statement VxWave Ultrasound Imaging System is an investigational device and has not been cleared by the U.S. Food and Drug Administration for commercial sale in the United States or by any other regulatory authority for commercial distribution.Source:
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Aug 06, 2026, 14:56 ET Sebi's Daughters Celebrates Ten Years of Advancing Dr. Sebi's Legacy of Healing
[email protected] statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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Aug 06, 2026, 13:52 ET CAPR INVESTOR DEADLINE: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit
allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without agreement from the U.S. Food and Drug Administration (FDA) prior to resubmitting its Biologics License Application (BLA).The HOPE-3 Trial Breakthrough and Subsequent Capital RaiseOn
More news about: Hagens Berman Sobol Shapiro LLP
Aug 06, 2026, 12:04 ET Northwest Biotherapeutics Announces MOU for Collaboration With the Saudi Pharmaceutical Industries and Medical Appliance Company
the execution of definitive agreements, the parties currently contemplate that SPIMACO would be responsible for interfacing with the Saudi Food and Drug Authority (SFDA), including the application for approval of DCVax-L for glioblastoma, and would be expected to serve as the Company's commercial partner
More news about: Northwest Biotherapeutics, Inc.
Aug 06, 2026, 12:01 ET Dr. Lynn Puana Announces the S&G Scholarship for Veterans to Support Student Service Members
S&G Labs remains dedicated to scientific innovation, accurate drug detection services, and supporting educational initiatives that strengthen communities.Website:
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Aug 06, 2026, 11:58 ET Northwest Biotherapeutics Announces MOU for Collaboration With the Saudi Pharmaceutical Industries and Medical Appliance Company
the execution of definitive agreements, the parties currently contemplate that SPIMACO would be responsible for interfacing with the Saudi Food and Drug Authority (SFDA), including the application for approval of DCVax-L for glioblastoma, and would be expected to serve as the Company's commercial partner
More news about: Northwest Biotherapeutics, Inc.
Aug 06, 2026, 11:29 ET NeuroSense Completes PrimeC Pre-NDS Process and Advances Toward December 2026 Filing with Health Canada
Canadian Agency for Drugs and Technologies in Health, now Canada's Drug Agency, oral edaravone carries an estimated annual drug-acquisition cost of approximately C$120,000 (approximately US$85,000) per patient. Actual prices paid by public drug plans may differ because of confidential pricing arrangements
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Aug 06, 2026, 10:31 ET The Next Billion-Dollar Opportunity in Alzheimer's Disease Market: 6 Pipeline Therapies to Watch | DelveInsight
improve gastrointestinal tolerability and long-term treatment adherence. Similarly, ALLYDONE transdermal donepezil patches provide an alternative drug delivery option designed to improve compliance, particularly among elderly patients. In addition, REXULTI (brexpiprazole) has broadened
More news about: DelveInsight Business Research, LLP
Aug 06, 2026, 10:30 ET Multiomics Market worth $5.70 billion by 2031 - Exclusive Report by MarketsandMarkets™
medicine and biopharmaceutical research, and rising adoption of genomics, transcriptomics, proteomics, epigenomics, and spatial omics technologies across drug discovery, biomarker identification, disease research, clinical research, and translational applications.North America accounted for the largest
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Aug 06, 2026, 09:30 ET Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
tests, today announced that it has submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission
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Aug 06, 2026, 09:15 ET CellCarta Adds Tempus to CDx Commercialization Lab Network
analytical platforms in immunology, histopathology, proteomics, and genomics, along with sample management and logistics services, CellCarta supports the drug development cycle from discovery to late-stage clinical trials. Visit cellcarta.com and connect with us on LinkedIn and X.Media ContactsStéphanie
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Aug 06, 2026, 09:06 ET Largest, Longest Real-World Study of Migraine in U.S. Veterans Finds that Nerivio® Helps Patients Successfully Skip Prescribed Migraine Medications in 3-out-of-4 of Their Migraine Attacks
pain-inhibitory pathways through Conditioned Pain Modulation (CPM), delivering targeted, drug-free relief. Cleared for patients aged 8 and older, it delivers patented electrical pulses without needles, systemic side effects, or drug interactions. Controlled through a smartphone app, Nerivio enables targeted, on-demand
More news about: Theranica
Aug 06, 2026, 08:30 ET Navigating the Shift from Animal Testing to NAMs in Drug Development, Upcoming Webinar Hosted by Xtalks
and discuss near- and long-term implications for drug development programs. The session will conclude with examples of reduced animal testing paradigms and the integration of NAMs and Model-Informed Drug Development (MIDD) approaches into sponsor drug development programs.For organizations planning
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Aug 06, 2026, 08:30 ET The9 Expands Brand Partnership Network Across Southeast Asia
continues to explore emerging opportunities across AI-empowered industries and the broader digital ecosystem, including an equity stake in AI-driven drug discovery company NYB, building a multi-engine business positioned at the frontier of AI and the new economy, reshaping how value is created and shared.
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Aug 06, 2026, 08:30 ET Roche expands cyclospora testing portfolio to support U.S. public health response
Cyclospora Outbreak Linked to Iceberg Lettuce in 9 States. Accessed July 24, 2026.U.S. Food and Drug Administration.
More news about: ROCHE DIAGNOSTICS CORPORATION