BioSpace6h
Days After BridgeBio Approval, FDA Agrees to Review Alnylam’s Amvuttra in ATTR-CM
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, ...
BioSpace6h
Biohaven Drug Misses in Phase III for SMA, Will Be Tested in Obesity
While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked ...
BioSpace6h
Adcendo Rides ADC Wave With $135M Series B
Adcendo joins a growing group of biotechs working to usher the next generation of antibody-drug conjugates to the market.
BioSpace9h
Trump Picks Vaccine Critic Weldon to Lead CDC, Makary for FDA Head
Career conservative and former congressman Dave Weldon will, if confirmed, act as director of the Centers of Disease Control ...
BioSpace16h
FDA Action Alert: Applied Therapeutics Awaits Verdict on Rare Disease Therapy
With two decisions originally scheduled for this week already announced, including BridgeBio's approval in ATTR-CM, the ...
BioSpace16h
Next-Gen ADCs Driving ‘Renaissance’ in Already Hot Oncology Drug Class
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and ...
BioSpace16h
Embattled Sage Dealt Deeper Blow With Huntington’s Failure
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts ...
BioSpace22h
Cassava’s Shares Plunge as Alzheimer’s Drug Fails Phase 3
Cassava Sciences has revealed the late-stage clinical failure of controversial Alzheimer’s drug simulfilam. The company had ...