Newsroom | 48845 results
Sorted by: Latest
-
Prilenia and Ferrer Announce FDA Clearance to Start the “PREVAiLS” Pivotal Phase 3 Study with Pridopidine in ALS
NAARDEN, The Netherlands & WALTHAM, Mass. & BARCELONA, Spain--(BUSINESS WIRE)--Prilenia Therapeutics B.V. and Ferrer today announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, randomized, placebo-controlled Phase 3 study of pridopidine in participants with rapidly progressive amyotrophic lateral sclerosis (ALS) early in their disease course. Recruitment is planned to begin at the first US clinical trial sites in early 2026, with sites in Eu...
-
Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI*
LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the EPO notified the Company of its intention to grant a patent application covering the liquid formulation of MOLBREEVI, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). “The liquid formulation and drug-device patents will provide protection in Europe through March 2041 and March...
-
Guardant Health Announces Collaboration with Trial Library to Increase Access to Cancer Clinical Trials Across the U.S.
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health (Nasdaq: GH), a leading precision oncology company, and Trial Library, an AI technology company enabling oncology clinical trials as a care option, today announced a strategic collaboration to increase access to cancer clinical trials in the United States. The collaboration combines Guardant Health’s suite of cutting-edge precision oncology diagnostics with Trial Library’s AI-powered matching and patient navigation platform. Together, the comp...
-
NiKang Therapeutics Presents Discovery of NKT5097, a First-in-Class, Highly Potent and Selective, Orally Bioavailable CDK2/4 Dual Degrader for Cancer Therapy at SABCS 2025
WILMINGTON, Del.--(BUSINESS WIRE)--NiKang Therapeutics Inc. (“NiKang”), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, today announced the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) being held December 9-12, 2025, in San Antonio, TX. NKT5097 is a first-in-class, orally bioavailable small molecule engineered to selectiv...
-
Valinor Raises $13 Million to Increase Clinical Trial Success Rates with Proprietary ML Models
SAN FRANCISCO--(BUSINESS WIRE)--Valinor, a pioneering AI company leveraging advanced machine learning models to increase the probability of clinical trial success by deeply understanding patient response, today announced $13 million in funding. The seed funding was led by CRV, Harpoon Ventures, Amino Collective, and Pelion Venture Partners. Other participants include numerous leading angel investors and operators such as Charlie Songhurst, Surya Midha (co-founder of Mercor), Axel Ericsson, and...
-
Medra Raises $52 Million Series A to Build Physical AI Scientists
SAN FRANCISCO--(BUSINESS WIRE)--Medra Raises $52 Million Series A to Build Physical AI Scientists...
-
Accenture Invests in Ryght AI to Help Life Sciences Companies Transform Clinical Research with Agentic AI
NEW YORK--(BUSINESS WIRE)--Accenture has invested in Ryght AI, a platform provider that modernizes how clinical research is designed and executed for the life sciences industry....
-
Veradermics Completes Enrollment in its Phase 2/3 Clinical Trial of VDPHL01 for Male Pattern Hair Loss, Advancing Development of the Potential First-Ever Extended-Release Oral Minoxidil
NEW HAVEN, Conn.--(BUSINESS WIRE)--Veradermics, Incorporated, a dermatologist-founded, late clinical-stage biopharmaceutical company developing potentially first-in-class therapeutics for common dermatologic conditions, today announced completion of enrollment in its Phase 2/3 registration-directed clinical trial evaluating VDPHL01, the potential first-ever extended-release oral minoxidil, for the treatment of male pattern hair loss. The company’s second Phase 3 male trial is actively enrolling...
-
U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE)--US FDA Grants Priority Review to Bristol Myers Squibb's Application for Opdivo (nivolumab) Plus Chemotherapy Combination for Classic Hodgkin Lymphoma...
-
Kyowa Kirin Announces Proposed Appointment of Abdul Mullick to President and Chief Executive Officer, While Former CEO Masashi Miyamoto to Remain Chairman
TOKYO--(BUSINESS WIRE)--Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the Board of Directors’ decision to appoint Abdul Mullick, Ph.D., currently President and Chief Operating Officer (COO), to the role of President and Chief Executive Officer (CEO). The appointment will become effective March 2026 following the conclusion of the Ordinary General Meeting of Shareholders. As Mullick takes on the role of President and CEO for...