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FDA+ channel feed
Roche to reintroduce ocular implant two years after pulling it off the market
10 months ago
Pharma
When can pharma companies correct online misinformation? FDA explains
10 months ago
Updated: Eli Lilly wins long-awaited approval for Alzheimer’s drug
10 months ago
Pharma
FDA says cancer drug cisplatin is no longer in shortage
10 months ago
Pharma
Manufacturing
Merck calls ACIP's pneumococcal recommendation a 'missed opportunity,' advocates for expanding age group
10 months ago
Pharma
CMS spells out how states can join new cell and gene therapy access pilot
10 months ago
Pharma
Why the Supreme Court's overrule of Chevron has major implications for the FDA
10 months ago
Pharma
Law
FDA rejects Rocket Pharma’s ultra-rare immune disease gene therapy over manufacturing
10 months ago
Cell/Gene Tx
Manufacturing
House panel advances bill to allow Medicare to cover obesity drugs
10 months ago
Pharma
AbbVie and Genmab score accelerated follicular lymphoma nod for Epkinly
10 months ago
Pharma
FDA rejects Daiichi Sankyo's HER3 ADC, a blow to quick approval plans for Merck partnership
10 months ago
R&D
Pharma
FDA approves new COPD drug from Verona Pharma
10 months ago
Pharma
Updated: CDC expands RSV vaccine recommendations, namely for adults 75 and older
10 months ago
Pharma
HHS reveals 64 drugs up for Medicare inflation rebates next quarter
10 months ago
Pharma
FDA publishes long-awaited guidance on clinical trial diversity
10 months ago
Q&A: FDA medical policy chief talks decentralized trial guidance, improving diversity
10 months ago
Pharma
FDA again rejects AbbVie's continuous infusion therapy for Parkinson's
10 months ago
Pharma
Manufacturing
House committee presses FDA on signs of inconsistent inspections in China and India
10 months ago
Manufacturing
Argenx wins second FDA approval for Vyvgart in autoimmune nerve disease
10 months ago
Pharma
Peter Marks single-handedly approved Sarepta’s gene therapy — what does that mean for everyone else?
10 months ago
Pharma
Cell/Gene Tx
Bristol Myers wins approval for KRAS drug Krazati in colorectal cancer
10 months ago
Pharma
FDA ships two Form 483s to Dr. Reddy’s for two separate sites in India
10 months ago
Manufacturing
Lexicon resubmits type 1 diabetes drug to FDA five years after rejection
10 months ago
FDA widens Sarepta’s Duchenne gene therapy label to older boys in significant expansion of use
10 months ago
Pharma
Cell/Gene Tx
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