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Sep 09, 2026, 10:28 ET ImmunoGenesis Announces Appointment of Reza Mazhari and Mike Davis to Its Board of Directors
appointment of Reza Mazhari, Ph.D., and Mike Davis to its Board of Directors. Dr. Reza Mazhari has more than 25 years of life science operating experience in drug discovery, early-stage clinical development and business and corporate development across diverse therapeutic areas including oncology. Mr. Davis brings
More news about: Immunogenesis Inc.
Sep 09, 2026, 10:07 ET REPL Deadline Alert: Levi & Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of Securities Class Action Deadline on October 5, 2026
requires substantial evidence of effectiveness from an adequate and well-controlled clinical investigation under Section 505(d) of the Federal Food, Drug, and Cosmetic Act, 21 C.F.R. § 314.126, and Section 351 of the Public Health Service Act. The April 10, 2026 Complete Response Letter stated that RPL-001-16
More news about: Levi & Korsinsky, LLP
Sep 09, 2026, 10:05 ET UNCY Shareholder Alert: November 2, 2026 Lead Plaintiff Deadline in Unicycive Therapeutics, Inc. Securities Class Action - Contact Levi & Korsinsky
one.Alleged Control Person LiabilityAuthority over the December 29, 2025 press release announcing resubmission of the OLC New Drug Application based on the original vendor's claimed "significant progress" toward regaining FDA complianceControl over annual and quarterly
More news about: Levi & Korsinsky, LLP
Sep 09, 2026, 10:03 ET Q'Apel Medical Announces U.S. Launch of the Lynx™ Aspiration Catheter System
portfolio focused on solving real-world procedural challenges with differentiated technology that exceeds expectations."Following its U.S. Food and Drug Administration (FDA) clearance, the Lynx System is now commercially available across the United States.Click here for
More news about: Q'Apel Medical Inc.
Sep 09, 2026, 10:00 ET PostEra's Fertility programs acquired by EMD Serono, Inc.
PostEra, a biotechnology company specializing in artificial intelligence for small molecule drug discovery and reproductive endocrinology, today announced that EMD Serono, Inc., the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S.
More news about: PostEra
Sep 09, 2026, 10:00 ET PostEra's Fertility programs acquired by EMD Serono, Inc.
PostEra, a biotechnology company specializing in artificial intelligence for small molecule drug discovery and reproductive endocrinology, today announced that EMD Serono, Inc., the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S.
More news about: PostEra
Sep 09, 2026, 09:30 ET AEYE-DS Clinical Trials Published: First Fully Autonomous Diabetic Retinopathy Screening Technology Across Portable and Tabletop Devices Demonstrates 99% Imageability, One-Image-per-Eye Workflow, and Best-in-Class Diagnostic Efficacy
studies with AEYE-DS in over 1,200 patients," reveals the multi-center clinical validation trials that earned the company its groundbreaking U.S. Food and Drug Administration (FDA) approvals.
More news about: AEYE Health
Sep 09, 2026, 09:28 ET Staying connected: Suicide prevention starts with awareness and action
signsSuicidal ideation may accompany:Mental health conditions such as anxiety or depressionIncreased alcohol or drug useToo much or too little sleepMedication side effectsUnresolved trauma, including exposure to distressing news or personal
More news about: Youth Villages, Inc.
Sep 09, 2026, 09:05 ET BioMarin Announces Positive Results of Phase 3 VOXZOGO® (vosoritide) Study in Hypochondroplasia Published in NEJM Evidence
medicine developed specifically for children with hypochondroplasia."BioMarin 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 and are on track with the submissions
More news about: BioMarin Pharmaceutical Inc.
Sep 09, 2026, 09:00 ET Rakuten Medical Appoints Christophe Weber as Vice Chairman and Ken Takeshita, M.D., as Director to Accelerate U.S. Growth and Oncology Innovation
technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700),
More news about: Rakuten Medical, Inc.
Sep 09, 2026, 09:00 ET Mighty Therapeutics Initiates IND-Enabling Studies of MYTX-255: a Mitochondrial-Targeted Therapeutic Candidate
IND-enabling studies of MYTX-255, a novel investigational mitochondrial-targeted therapeutic candidate. The Company plans to submit an Investigational New Drug (IND) application for MYTX-255 by year-end 2027.
More news about: Mighty Therapeutics
Sep 09, 2026, 09:00 ET CLEARSTEM Skincare Launches Into Target Beauty Studio, Bringing Root-Cause Care for Breakouts + Aging to Millions Nationwide
Skin conditions by the numbers."*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
More news about: CLEARSTEM
Sep 09, 2026, 09:00 ET $1 Million Awarded to Social Impact Student Start-Up at 2026 EF Hult Prize
Biosciences (Germany, University of Cologne) – Fluorescent imaging technology that lets scientists watch how fat is processed inside living cells in real time to aid drug discovery.PolarDoc (United States, Florida International University) – A device designed to identify preterm birth
More news about: EF Hult Prize Foundation
Sep 09, 2026, 09:00 ET $1 Million Awarded to Social Impact Student Start-Up at 2026 EF Hult Prize
Biosciences (Germany, University of Cologne) – Fluorescent imaging technology that lets scientists watch how fat is processed inside living cells in real time to aid drug discovery.PolarDoc (United States, Florida International University) – A device designed to identify preterm birth
More news about: EF Hult Prize Foundation
Sep 09, 2026, 08:55 ET CUBEX launches Essentials
A new product line for the veterinary hospitals still managing controlled substances on paper, starting with a smart cabinet that writes the drug log as the work happens.SCOTTSDALE, Ariz., Sept. 9, 2026 /PRNewswire/
More news about: CUBEX®
Sep 09, 2026, 08:32 ET Michael J. Fox Receives Lasker~Bloomberg Public Service Award for Transformative Leadership in Parkinson's Research
landscape, helping build the most robust therapeutic pipeline in the disease's history and cultivating a research ecosystem that has supported 23 new drug approvals over the past decade. Today, MJFF now invests significantly more in Parkinson's research each year than the U.S. federal government.Fox
More news about: The Michael J. Fox Foundation for Parkinson's Research
Sep 09, 2026, 08:25 ET Full-Life Technologies Announces U.S. FDA IND Clearance and Australian Regulatory Clearance for [²²⁵Ac]Ac-FL-261 Phase 1 Clinical Trial
company, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for [225Ac]Ac-FL-261 and that the program has received
More news about: Full-Life Technologies
Sep 09, 2026, 08:00 ET 1cBio and Lee's Pharmaceutical Holdings Limited Enter into Exclusive Licensing Agreement to Develop and Commercialize 1cBio's PARP1 Inhibitor OC-3 for Oncology in Greater China and Southeast Asia
included in the license. A drug supply manufacturing agreement is also included.As part of the agreement, 1cBio will have rights to access and use any data generated as part of its efforts to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). About
More news about: 1cBio, Inc.
Sep 09, 2026, 08:00 ET UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)
organizational commitment to support efficient development and review, and is not a label indication approval.About Orphan Drug Designation12 Orphan Drug Designation is granted by the FDA to medicines intended for the treatment, prevention, or diagnosis of rare diseases or
More news about: UCB
Sep 09, 2026, 08:00 ET MetaVia Announces Preclinical Findings Supporting Biological Rationale for DA-1726's Waist Circumference Reduction
preclinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple
More news about: MetaVia Inc.
Sep 09, 2026, 08:00 ET Ratio Therapeutics Enters into Research Collaboration and License Agreement with RayzeBio to Advance a Novel Radiopharmaceutical Program
development of fit-for-purpose heterobifunctional radiopharmaceuticals for therapy and imaging that possess pharmacokinetic modulation, thereby improving drug availability, tumor delivery, and tumor loading. The company maintains a strong commitment to manufacturing through its hybrid manufacturing approach
More news about: Ratio Therapeutics Inc.
Sep 09, 2026, 08:00 ET Clearway Health Scales Operational Excellence with Appointment of Chief Operating Officer
hiring and embedding skilled pharmacists and patient liaisons into the clinical team.Deliver proprietary software technology.Unlock drug access and lead accreditation processes.Grow revenue at healthy margins for health systems and reduce costs for patients.To learn
More news about: Clearway Health
Sep 09, 2026, 08:00 ET Ultima Genomics to Advance Pangenome-Aware Whole Genome Sequencing Analysis at Population Scale in Collaboration with NVIDIA, using Google's DeepVariant
unparalleled scale of Ultima sequencing and the speed of NVIDIA, the genomics community can start a flywheel where new datasets further improve diagnostics and drug discovery and create tools and analysis standards openly available to the broader science community."The joint work reflects a shared commitment
More news about: Ultima Genomics
Sep 09, 2026, 08:00 ET Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System
/PRNewswire/ -- Emboline, Inc., a medical technology company developing next-generation embolic protection technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Emboliner® Embolic Protection System for use during transcatheter heart procedures.
More news about: Emboline, Inc.
Sep 09, 2026, 08:00 ET Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System
/PRNewswire/ -- Emboline, Inc., a medical technology company developing next-generation embolic protection technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Emboliner® Embolic Protection System for use during transcatheter heart procedures.
More news about: Emboline, Inc.