Techno Trends
Techno Trends includes advancements and innovations in pharmaceutical products and technology from around the world. Additionally, you may keep abreast of any recent advancements in the pharmaceutical industry (product information and technological trends).
FDA Grants Breakthrough Therapy Designation to GSK5764227 for Refractory Osteosarcoma
GSK has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to GSK5764227 (GSK’227), an antibody-drug conjugate (ADC) targeting B7-H3....
Rezolute Receives Breakthrough Therapy Designation for Ersodetug (RZ358) in Hypoglycemia Treatment
Rezolute announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ersodetug (RZ358) for addressing hypoglycaemia caused by congenital hyperinsulinism (HI)....
U.S. FDA Grants Breakthrough Therapy Designation to Tividenofusp Alfa for Hunter Syndrome
Denali Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) as a potential treatment for Hunter syndrome (MPS II). ...
Allay Therapeutics Receives FDA Breakthrough Designation for ATX101 in Post-Knee Surgery Pain
Allay Therapeutics has announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to its lead investigational product, ATX101. This designation is for the treatment of post-surgical pain following total knee arthroplasty (TKA) in adults....
Merck Secures Breakthrough Therapy Designation for Sacituzumab Tirumotecan (sac-TMT) in Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Merck has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT). This investigational therapy is aimed at treating patients with advanced...
Hansoh Pharma Receives Breakthrough Therapy Designation for HS-20093 in Treating Extensive-Stage Small Cell Lung Cancer
Hansoh Pharmaceutical has announced that its self-developed B7-H3-targeted antibody-drug conjugate (ADC), HS-20093, has been designated as a Breakthrough Therapy by China’s National Medical Products Administration (NMPA). ...
Jazz Pharmaceuticals Breaks Ground on Ziihera® for Treatment of HER2-Positive Biliary Tract Cancer
Jazz Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL for intravenous use. The treatment is intended for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC), identified through an FDA-approved diagnostic test....
FDA Grants Breakthrough Therapy Designation to Nipocalimab for Moderate-to-Severe Sjogren's Disease in Adults
The investigational monoclonal antibody nipocalimab has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for treating moderate-to-severe Sjögren's disease (SjD) in adults. ...
Boehringer Ingelheim Earns FDA Breakthrough Designation for Survodutide in MASH with Advanced Liver Fibrosis
The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to Boehringer Ingelheim’s survodutide (BI 456906). This dual agonist targets both glucagon and GLP-1 receptors and is designed to treat adults with metabolic dysfunction-associated steatohepatitis...
FDA grants Breakthrough Therapy designation for denifanstat by Sagimet in MASH
Sagimet Biosciences has announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to denifanstat. This designation is for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH)...
