BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of…
Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN)….
Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA)…
Yiviva Announces Memorandum of Understanding with AstraZeneca to Develop Platforms, Technologies, and Innovative Therapeutics through a Systems Biology Approach
Yiviva, a clinical-stage, platform biotechnology company developing systems biology medicines to treat aging-related diseases, signed a memorandum of understanding (MOU) with AstraZeneca China to establish a research and development collaboration at AstraZeneca’s Innovation Campus (iCampus) in Chengdu, China. The signing…
Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces it plans to expand the…
Bracco Announces Long-Term Strategic Partnership with ulrich medical for Syringeless Magnetic Resonance Injectors
Bracco, a global leader in diagnostic imaging, and ulrich GmbH & Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants, announced today a new long-term partnership that will bring a Bracco-branded, state-of-the-art MR…
Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat
Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for…
MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil
MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast…
European Medicines Agency Validates Type II Variation for Astellas’ XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also…
AIRS Medical Inc. receives MDSAP Certification, Paving the Way for Global Expansion
AIRS Medical Inc., an AI-powered healthcare solution provider headquartered in Korea announces the attainment of MDSAP (Medical Device Single Audit Program) certification. This milestone achievement underscores AIRS Medical’s commitment to quality excellence on a global scale, further propelling the company’s…
