FDA
ZOLL Receives FDA Clearance and CE Mark to Expand the Thermogard Platform – All-In-One Core and Surface Cooling
08/01/2024 — CHELMSFORD, Mass. — (BUSINESS WIRE) ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that it has received FDA clearance and CE […]
Airway Therapeutics Completes Enrollment in Phase 1b Trial of Zelpultide Alfa (AT-100) for Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
05/06/2023 — ATLANTA — (BUSINESS WIRE) Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory […]
Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema
OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter […]
Agendia Announces First Patient Enrolled in Prospective LESS Clinical Study, Sponsored by Unicancer, to De-escalate Endocrine Therapy in Women with Early Breast Cancer
The LESS study will evaluate reduced endocrine therapy for HR+/HER2- patients with MammaPrint® Ultra Low tumors to improve quality of life without compromising outcomes Study strengthens Agendia’s growing global footprint […]
New Medidata Technology Helps Sponsors and CROs Improve Diversity and Inclusion in Clinical Trials
Intelligent Trials Diversity Module Addresses Critical Need to Increase Study Access and Engagement 13/10/2022 — NEW YORK — (BUSINESS WIRE) Medidata, a Dassault Systèmes company, has launched the Intelligent Trials […]
Agendia Presents Data from the FLEX Real World Evidence Trial in Seven Posters at ASCO 2022, Showcasing the Power of Its 30,000-Patient Breast Cancer Genome Project
Data show MammaPrint® is the first and most comprehensive FDA-cleared test for early breast cancer resulting in the ability to identify women who may be over- or under-treated if treatment […]
Premier Reaches Market First with Revolutionary Sustainable Product
11/11/2021 — LOUISVILLE, Ky. — (BUSINESS WIRE) As world leaders discuss ways to limit global warming at the United Nations Climate Change Conference in Scotland, Premier Packaging is first to […]
Innovative Health Sciences Receives FDA Clearance for Insignis™ Subcutaneous Needle Sets
26/08/2021 — CHESTER, N.Y. — (BUSINESS WIRE) Innovative Health Sciences, LLC (“IHS” or the “Company”) management announced today that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. […]
Adagio Therapeutics Appoints Leading Pharmaceutical and Regulatory Executives to its Board of Directors
29/07/2021 — WALTHAM, Mass, — (BUSINESS WIRE) Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, […]
Adagio Therapeutics Announces $336 Million Series C Financing to Support Rapid Advancement of Novel ADG20 #Antibody for the Treatment and Prevention of #COVID-19
Additional Capital to Fund Ongoing STAMP Pivotal Trial of ADG20 Designed to Support Emergency Use Authorization Submission Financing Follows First Quarter Appointment of Industry and Banking Veteran Jane Henderson as […]
Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate
Trial to enroll up to 30,000 volunteers worldwide Fast Track designation granted by US FDA Feasibility study initiated of a vaccine candidate to address emerging variants 16/03/2021 — QUEBEC CITY […]
MED™ 3D Printed Pharmaceutical Product Receives IND Clearance From the US FDA
Triastek Opens a New Chapter for Digital Formulation Development and Intelligent Pharmaceutical Manufacturing 09/02/2021 — NANJING, China — (BUSINESS WIRE) Triastek, Inc. (“Triastek”), a pharmaceutical company specializing in 3D printing […]
Aurinia Announces Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd. for the Development and Commercialization of Voclosporin in Europe and Japan
– Aurinia to receive $50 million U.S. upfront payment in addition to up to $50 million U.S. in regulatory and reimbursement milestone payments – – Agreement includes royalties of up […]
NeuroRx and Relief Therapeutics Announce Data Monitoring Committee Determination to Continue Phase 2/3 Trial of RLF-100 for Critical COVID-19
With resurgent COVID-19, enrollment has accelerated in Miami, Houston, and Irvine Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns […]
NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19
Fast Track Designation of RLF-100 for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19 underscores the urgent need for new treatment options for these patients. At […]
Asuragen Develops Armored RNA Quant® SARS-CoV-2 Control
New reference material aims to facilitate and expedite global efforts to detect the novel coronavirus 16/03/2020 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc. has developed an Armored RNA Quant® […]
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21/12/2019 — LONDON — (BUSINESS WIRE) ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter […]
US FDA Action Enables Millions of American Smokers to Give Up Cigarettes
Philip Morris International and Altria Will Make Better Choices Available Through Socially Responsible Practices 07/05/2019 — NEW YORK — (BUSINESS WIRE) Second paragraph, second sentence of release should read: PMI […]
Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe
Arvelle Therapeutics GmbH to provide SK Biopharmaceuticals an upfront payment of $100 million with future milestone potential of up to $430 million A new CNS-focused company, Arvelle received one of […]
Asuragen Launches Assay to Aid in the Diagnosis of Myotonic Dystrophy Type I (DM1)
The AmplideX® DM1 Dx Kit is now available in countries accepting the CE mark 04/12/2018 — AUSTIN, Texas — (BUSINESS WIRE) Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products […]
GORE® Molding & Occlusion Balloon for Endovascular Aortic Repair Receives Approval in the United States, Japan, and Europe
New balloon addresses EVAR stent graft seal and temporary vessel occlusion challenges 23/08/2018 — FLAGSTAFF, Ariz. — (BUSINESS WIRE) W. L. Gore & Associates, Inc. (Gore) announced FDA 510(k) clearance, […]
Mevion Receives 510(k) Clearance for HYPERSCAN Pencil Beam Scanning
03/01/2018 — LITTLETON, Mass. — (BUSINESS WIRE) Mevion Medical Systems has received FDA 510(k) clearance for the MEVION S250i Proton Therapy System® including HYPERSCAN™ pencil beam scanning (PBS) technology. HYPERSCAN […]
Emmaus Life Sciences Sickle Cell Treatment Receives Positive Opinion on Pediatric Investigation Plan from European Medicines Agency
22/12/2017 — TORRANCE, Calif. — (BUSINESS WIRE) Emmaus Life Sciences announced today that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has accepted the company’s pediatric investigation plan (PIP) […]
Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm
“Minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy” 06/10/2017 — CLARENCE, N.Y. — (BUSINESS WIRE) 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology […]
LFB S.A. Announced Today the Acceptance by U.S. Food and Drug Administration of the Filed Biologic License Application for Coagulation Factor VIIa Recombinant, (eptacog beta activated)
06/01/2017 — LES ULIS, France — (BUSINESS WIRE) LFB S.A., announced that its Biologic License Application (BLA), requesting marketing approval of Coagulation Factor VIIa (Recombinant) as a treatment for congenital […]
Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System.
Topline Accuracy of 8.8% MARD (Mean Absolute Relative Difference) over 90 Days. 09/08/2016 — GERMANTOWN, Md. — (BUSINESS WIRE) Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development […]
European Commission Grants Marketing Authorisation for MSD’s ZEPATIER™ (elbasvir/grazoprevir) for the Treatment of Chronic Hepatitis C Infection
In Phase 3 Clinical Trials, ZEPATIER Achieved High Cure (SVR) Rates Across Diverse Populations of Patients With Chronic Hepatitis C, Including Those With Compensated Cirrhosis, Renal Impairment or on Opioid […]
ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma
First pivotal study for Merck and Pfizer’s investigational anti-PD-L1 antibody avelumab shows clinically meaningful tumor responses in pre-treated metastatic Merkel cell carcinoma (MCC) International, multicenter Phase II study results in […]
Merck and Pfizer to Present Avelumab Data in Seven Different Cancers at ASCO Annual Meeting
14 avelumab abstracts at ASCO 2016 highlight significant progress being made by the collaboration between Merck and Pfizer Two oral presentations: avelumab investigated as a second-line treatment for metastatic Merkel […]