DURAVYU Phase 3 setback leaves EyePoint relying on second pivotal wet AMD trial
DURAVYU misses its Phase 3 wet AMD endpoint despite cutting treatment burden 42%. See why EyePoint’s upcoming LUCIA trial is now critical.
Pharma & Biotech
Pharma & Biotech
UroGen takes UGN-103 to FDA as non-surgical bladder cancer strategy expands
UroGen files UGN-103 with the FDA after a 77.8% Phase 3 complete response rate as its bladder cancer franchise gains commercial momentum.
Pharma & Biotech
FDA clears Shanghai Ark Biopharmaceutical’s ziresovir Phase 2 trial in critically ill infants with RSV
Shanghai Ark Biopharmaceutical Co., Ltd. ((ArkBio) has received authorization from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 trial of ziresovir, an oral antiviral being developed for infants with severe respiratory syncytial virus infection, including patients requiring treatment in a pediatric intensive care unit. The planned multicenter, randomized, double-blind and placebo-controlled
Pharma & Biotech
Capricor plans deramiocel BLA amendment with 24-month HOPE-3 data
Capricor Therapeutics says the United States Food and Drug Administration (FDA) is willing to review an amendment containing 24-month HOPE-3 data for deramiocel, keeping the experimental Duchenne muscular dystrophy cell therapy under active consideration despite a strongly negative advisory committee vote. The company intends to narrow the regulatory case from Duchenne-associated cardiomyopathy to preservation of
Pharma & Biotech
Bristol Myers Squibb wins first FDA approval for a CELMoD therapy
Bristol Myers Squibb has secured accelerated approval from the United States Food and Drug Administration for Zenbexus, making iberdomide the first therapy from the company’s CELMoD class to reach the US market. The oral drug was approved as part of a three-drug regimen with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma
Pharma & Biotech
Actinium expands Actimab-A intellectual property as Actinium-225 manufacturing becomes a strategic priority
Actinium advances Actimab-A IP and manufacturing while NYSE American compliance adds a parallel financing and execution test.
Pharma & Biotech
Fannin’s Ewing sarcoma bet is not an antibody-drug conjugate. Can RapDCs clear the next hurdle?
Fannin secured new grants to advance an IL1RAP-targeted RapDC for Ewing sarcoma, moving its synthetic drug-conjugate platform toward proof of concept.
Pharma & Biotech
What the $46m Veloxis Pharmaceuticals settlement means for Envarsus XR
Veloxis Pharmaceuticals will pay over $46 million over Envarsus XR conduct. See why five years of compliance oversight could matter even more.
Pharma & Biotech
Aizen Therapeutics just put a $100 million-per-target test on its AI-designed oral biologics platform
Aizen Therapeutics lands an oral peptide collaboration with several million dollars upfront and up to $100 million in milestones per target.
Pharma & Biotech
How Insilico Medicine’s Virtual Aging Cell could bring biological time into AI drug discovery
Insilico Medicine is building an age-aware Virtual Aging Cell for drug discovery, but experimental validation will determine its real scientific value.