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about the author
Lia DeGroot
ldegroot@endpointsnews.com
author articles
FDA approves first generics for Takeda’s Vyvanse as ADHD drug shortages persist
Last year
Pharma
FDA+
'FDA is not a physician,' appeals court rules in case against agency's ivermectin messaging
Last year
Pharma
FDA+
FDA offers clarity on post-warning letter meetings in new draft guidance
Last year
Pharma
FDA+
Lilly, Novo, Sanofi face pressure from lawmakers to clarify low-cost insulin programs
Last year
Pharma
FDA+
Democrat lawmakers call on FDA to take steps to prevent misuse of Orange Book
Last year
Pharma
FDA+
FDA+ roundup: FDA issues final guidance on use of real-world evidence
Last year
R&D
Pharma
Pfizer challenges Moderna Covid vaccine patents before Patent Trial and Appeal Board
Last year
Pharma
Law
FDA to hold off on enforcing some parts of major supply chain law until 2024
Last year
Pharma
FDA+
AstraZeneca disputes IRA’s orphan drug provisions in latest legal challenge to the law
Last year
Pharma
FDA+
CMS’ Medicare negotiation list is coming next week. Here’s what to expect
Last year
Pharma
FDA+
In PhIII data, Eli Lilly’s Retevmo meets primary endpoint of improving progression-free survival
Last year
R&D
Pharma
Biden awards $24M to develop mRNA tech targeting cancer, other diseases
Last year
R&D
Pharma
Operation Warp Speed redux: HHS awards $1.4B to develop next-gen Covid-19 drugs and vaccines
Last year
Pharma
FDA+
CMS lays out how seniors can pay for drugs on a monthly basis in 2025 and beyond
Last year
Pharma
FDA+
FDA sets October adcomm to discuss full approval for Amgen’s Lumakras to treat second-line lung cancer
Last year
Pharma
FDA+
AARP, in amicus brief, argues that CMS negotiating drug prices is in the public interest
Last year
Pharma
FDA+
FDA issues rare notice of noncompliance for not reporting clinical trial results
Last year
FDA+
Florida adds neglected FOIA requests to amended lawsuit against FDA over drug imports
Last year
Pharma
FDA+
Q&A: FDA's Peter Marks ready to encourage more accelerated approvals for rare diseases
Last year
People
FDA+
Amgen, Horizon urge judge to uphold constitutionality arguments against FTC
Last year
Deals
Pharma
Novo Nordisk buckles down on lobbying efforts, inching toward CMS coverage of obesity treatments
Last year
Pharma
FDA+
FDA lays out postmarketing approaches for data collection from underrepresented groups
Last year
Pharma
FDA+
FDA+ roundup: FDA continues to loosen standard of evidence for novel drug approvals — JAMA research letter
Last year
R&D
FDA+
DOD taps Valisure to carry out drug quality reviews amid generic shortages, concerns
Last year
FDA+
Manufacturing
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