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BioSpace
15 分钟
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, ...
BioSpace
10 小时
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 ...
BioSpace
10 小时
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 ...
BioSpace
10 小时
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 ...
BioSpace
2 天
Trump’s ‘Team of Self Promoters’ Will Make for Great Reality TV but an Uncertain ...
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has ...
BioSpace
4 天
Novartis Buys Kate Therapeutics, Eyeing $55B CGT Market Opportunity by 2030
Novartis’ up to $1.1 billion acquisition of gene therapy specialist Kate Therapeutics fits with the pharma’s plan to expand ...
BioSpace
3 天
Merck’s Former Asthma Blockbuster Singulair Could Be Linked to Mental Health Problems ...
A Reuters report on Friday revealed that FDA researchers have found additional molecular evidence tying blockbuster asthma ...
BioSpace
3 天
AstraZeneca Fends Off Adcomm’s Safety Concerns on Andexxa, Axes Mid-Stage Opioid Use ...
The pharma is seeking full approval for its anticoagulation reversal drug Andexxa, which the FDA granted accelerated approval ...
BioSpace
3 天
FDA Still Undecided About Shortage Status of Lilly’s Tirzepatide
Pending the FDA’s decision, compounding pharmacies will remain free to make and market versions of the blockbuster ...
BioSpace
4 天
COVID-19 Critic Marty Makary Is Trump’s Likely Pick for FDA Top Post
Makary is a pancreatic surgeon at Johns Hopkins who became known for battling medical mistakes and in recent years has been ...
BioSpace
5 天
Novo, Viking Heat Up MASH Space with Promising Data at AASLD24
Readouts from Novo Nordisk and Viking Therapeutics at AASLD 2024 strengthen the argument for GLP-1 therapies as an emerging ...
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