Browsing Tag
FDA
293 posts
AbbVie’s ELAHERE demonstrates 32% reduction in death risk for ovarian cancer patients
A final analysis of the Phase 3 MIRASOL trial has confirmed that ELAHERE (mirvetuximab soravtansine-gynx) provides a significant…
Dr. Reddy’s Laboratories recalls Levetiracetam Injection in U.S. over mislabeling concerns
Dr. Reddy’s Laboratories Limited has initiated a nationwide recall of a batch of Levetiracetam in 0.75% Sodium Chloride…
Capricor Therapeutics advances deramiocel toward FDA approval with priority review
Capricor Therapeutics has reached a significant milestone in its efforts to develop a novel treatment for Duchenne muscular…
Biocon Biologics reports positive Phase 3 results for Yesintek, biosimilar to Ustekinumab
Biocon Biologics Ltd., a global leader in biosimilar medicines and a subsidiary of India’s pioneering biopharmaceutical giant Biocon…
Longeveron 2024 revenue jumps 237%, eyes FDA approval for Lomecel-B
Longeveron Inc., a biotechnology company specializing in regenerative medicine, has reported significant financial progress alongside major advancements in…
Breakthrough in kidney cancer imaging: FDA fast-tracks Telix Pharmaceuticals’ TLX250-CDx
The United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Telix Pharmaceuticals…
More affordable Zepbound? Lilly’s new pricing plan shakes up obesity treatment
Eli Lilly and Company (Lilly) has introduced new single-dose vials of Zepbound (tirzepatide), expanding treatment options for self-pay…
Adial Pharmaceuticals secures FDA support for AD04 as Phase 3 clinical trials move forward
Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in addiction treatment development, has received a pivotal endorsement from…
MeiraGTx’s rAAV8.hRKp.AIPL1 shows remarkable efficacy in treating severe retinal dystrophy
A gene therapy developed by MeiraGTx Holdings plc has demonstrated remarkable success in restoring vision to children born…
NKGen Biotech administers first dose of troculeucel for FTD under FDA-cleared compassionate use
NKGen Biotech, Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company specializing in natural killer cell therapy, has taken a…