Bristol Myers wins accelerated FDA approval for Zenbexus, first CELMoD therapy for multiple myeloma
The FDA cleared Bristol Myers Squibb's Zenbexus (iberdomide), the first drug in the new CELMoD class, for patients with relapsed or refractory multiple myeloma
BioPharma Dive · +12 outlets
FDA approves engineered viral immunotherapy RP1 from Replimune for treatment-resistant advanced melanoma
Replimune's RP1, a genetically engineered oncolytic virus, received FDA approval for advanced melanoma that has not responded to prior therapies, expanding immu
Gulf Coast Media · +11 outlets
FDA grants accelerated approval to Regeneron's gene therapy for genetic hearing loss
Regeneron's investigational gene therapy for a form of genetic hearing loss received accelerated FDA approval, with a drug pricing deal with the White House exp
Stocktwits · +13 outlets
Moderna wins FDA approval for new, more effective flu vaccine
The FDA approved Moderna's mRNA-based flu vaccine, which the company says is more effective than current seasonal flu shots, expanding the mRNA platform beyond
AOL.com · +14 outlets
FDA clears Allogene's TALEN-edited cell therapy for lymphoma under accelerated pathway
Allogene Therapeutics received FDA accelerated approval for its CRISPR (TALEN)-edited allogeneic CAR T-cell therapy for lymphoma, a milestone for off-the-shelf
CRISPR Medicine News
UMass Chan mRNA immunotherapy eliminates pancreatic tumors in half of treated mice
Researchers at UMass Chan Medical School showed that an mRNA-based immunotherapy eliminated pancreatic tumors in half of treated mice, a promising step for a no
News Link Live · +2 outlets
Skye and Redx combine with $125M to advance fibrosis drug pipeline
Skye Biosciences and Redx Pharma agreed to merge in a reverse transaction valued at $125 million, pooling resources to develop fibrosis-focused therapies.
Fierce Biotech · +5 outlets
Stand Up To Cancer Nicolai Award to fund KRAS-targeted immunotherapy combination for pancreatic cancer
A new research award will fund a combination of KRAS-targeted therapy and immunotherapy for pancreatic cancer, aiming to attack one of the most challenging canc
The Cancer Letter · +3 outlets
Epicrispr closes $90M Series C for first epigenetic therapy for FSHD
Epicrispr raised $90 million to push its epigenetic therapy for facioscapulohumeral muscular dystrophy (FSHD) into pivotal trials, potentially the first medicin
Wowtale · +7 outlets
PhenoNet cleared by FDA to begin Phase 3 trial of inhaled gene therapy for early Alzheimer's
The FDA approved the start of a Phase 3 trial for PhenoNet's inhaled PHENOGENE-1A gene therapy targeting early Alzheimer's disease.
BioSpace · +3 outlets
FDA Type C Meeting granted for pulmonary metastatic osteosarcoma therapy
The FDA granted a Type C meeting to discuss a therapy for pulmonary metastatic osteosarcoma, advancing potential treatment for this rare bone cancer.
CancerNetwork · +7 outlets
Capricor soars on plan to amend DMD filing after FDA adcomm setback
Capricor Therapeutics shares rose after its CEO said the FDA is willing to review an updated submission for its Duchenne muscular dystrophy cell therapy followi
BioPharma Dive · +2 outlets
LSD-based therapy beats Phase 3 trials twice, faces regulatory and commercial hurdles
An LSD-based psychedelic therapy succeeded in two Phase 3 trials, but the developer now must navigate FDA approval and the challenges of commercializing a psych
The Clinical Trial Vanguard
InduPro raises $77M, begins first human trial of cancer drug
Seattle-based InduPro raised $77 million and initiated its first-in-human clinical trial for a novel cancer therapy targeting protein interactions.
GeekWire · +3 outlets
Boulevard emerges from stealth with $65M to develop autoimmune disease treatments
Boulevard launched with $65 million in financing to develop a new platform for autoimmune disease therapies, targeting conditions like lupus and rheumatoid arth
BioXconomy · +2 outlets
Soticlestat revived by Perceptive Advisors after FDA rejection
Perceptive Advisors is betting that the FDA rejected soticlestat's clinical trial design, not the drug itself, and plans to pursue a new development path for th
Tech Times
Khartis Therapeutics launches with $95M for oral thyroid eye disease drug
Khartis, founded by a Pfizer veteran, launched with $95 million to develop an oral treatment for thyroid eye disease, a condition currently treated with infusio
finance.biggo.com · +3 outlets
FDA grants clearance for denifanstat Phase 3 trial in moderate to severe acne
The FDA cleared a Phase 3 trial of denifanstat, a novel oral therapy for moderate to severe acne, advancing a potential non-antibiotic treatment option.
The Clinical Trial Vanguard · +5 outlets