SPOTLIGHT -
Massive Bio, ONCOassist Launch Strategic Partnership
Collaboration to focus on enhancing physician engagement in clinical trials and cancer research.
Levita Magnetics Announces First Commercial Use of MARS Surgical System
The system was used by doctors at the Cleveland Clinic.
Caris Life Sciences, Moderna Ink Strategic Partnership Agreement
Collaboration to focus on advancing mRNA-based oncology therapeutics.
FDA Approves Medinol’s Drug-Eluting Coronary Stent System
The EluNIR-PERL drug-eluting stent is used for the treatment of coronary artery disease.
RegCell Hires Michael McCullar as CEO
Company’s new leader previously served in the same role at OnQuality Pharmaceuticals.
PacBio Adds David Meline to Board of Directors
Executive previously served as chief financial officer of Moderna, Amgen, and 3M.
FDA Clears IND for Kyverna Therapeutics’ Scleroderma Treatment
KYV-101 designed as a CD19 CAR T-cell therapy.
Sapio Sciences Launches New Molecule Solution Platform
Sapio chemistry solution unifies small-molecule and large-molecule discovery workflows on a single platform.
FDA Grants Orphan Drug Designation to Thrombotic Thrombocytopenic Purpura Drug
GC1126A is designed to treat the rare blood disorder.
Azzur Group Appoints James Kalinovich as Chief Financial Officer
Kalinovich previously worked at Wabtec as a corporate vice president.
FDA Clears Global Phase III Trials for Osemitamab
The gastric/gastroesophageal cancer treatment is produced by Transcenta.
Syneos Health Appoints Colin Shannon as CEO
Exec joins the organization with decades of biopharma experience.
NeuroSense Therapeutics Terminates At-The-Market Equity Offering Program
The company announced that it is fully funded beyond clinical Phase IIb ALS results.
FDA Approves Enable Injections’ Wearable Injector
The injector is designed for at-home or in-clinic use.
Ceribell Names Joshua Copp as Chief Operating Officer
Copp comes to the company from McKinsey & Co.
FDA Approves Fabre-Kramer Pharmaceuticals Major Depressive Disorder Treatment
EXXUA has been approved for treatment.
Peptone Appoints New Leaders to C-Suite
The company announced new hires for its chief scientific officer, chief business officer, and other leadership roles.
Implicity Appoints Jon Hunt, PhD, as Chief Commercial Officer
Hunt joins the company from HeartBeam.
CDC Recommends First Vaccine to Protect Infants from RSV
Abrysvo reportedly reduces risk of condition in baby by 57% in the first six months after birth.
European Commission Approves Tepkinly for Adults With Relapesed or Refractory Diffuse Large B-cell Lymphoma
The treatment is approved for conditional marketing authorization.
FDA Clears Investigational New Drug Application for Influenza Antiviral
Via Nova Therapeutics’ VNT-101 is an Influenza A nucleoprotein inhibitor.
908 Devices Launches Real-Time Monitoring Platform For Multiple Bioprocess Parameters
The device, Maverick, utilizes Raman spectroscopy for bioprocess control.
Novo Nordisk Foundation Commits $135M to New Cell Therapy Facility
Location aims to translate research into multiple real-world treatments.
Nanoscope Therapeutics Announces the Appointment of Samuel Barone, MD, as Chief Medical Officer
Barone is a former FDA officer.
FDA Grants Fast Track Designation to Polycythemia Vera Treatment
The drug, 9MW3011, is also approved for clinical study by NMPA.
FDA Approves Jardiance for Adults With Chronic Kidney Disease
The blockbuster drug has previously been approved to treat multiple heart and diabetes-related conditions.
FDA Grants IDE Approval to Study of CereVasc’s eShunt System
The system will be part of a NPH study.
FDA Approves Talicia for sNDA
The drug now has a new approved dosing schedule.
FDA Clears Precision BioLogic’s Factor VIII Deficient Plasma with VWF For Sale in the US
The agency granted the treatment with 510(k) clearance.
National Institute of Allergy and Infectious Disease Awards Grant to ResVita Bio
ResVita will use the money to develop a treatment for severe atopic dermatitis.
