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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Approves Brytly (apraclonidine) Ophthalmic Solution for Relief of Eye Redness
GENEVA--(BUSINESS WIRE) October 16, 2026 -- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that the U.S....
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Regulatory Intelligence & Drug Approvals3 weeks agoRegulatory Pharmaceutical Fellowship Program
Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and industry, offering specialized training in regulatory science, policy, and drug development. Learn how to...
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Regulatory Intelligence & Drug Approvals3 weeks agoOther | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Approves New Nonprescription Eye Drop for Relief of Eye Redness
CDER Statement: FDA Approves New Nonprescription Eye Drop for Relief of Eye Redness
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA ‘reset’ continues with new plan for reviewing rare disease drugs
A revamped regulatory framework may give investors less of a “guessing game” as they weigh chances for drug approvals, one analyst said.
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA issues warning over Eurofins’ selective recording that ‘compromises’ data
Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.
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Regulatory Intelligence & Drug Approvals3 weeks agoCHMP backs Lilly’s oral GLP-1 Foundayo for EU approval
Eli Lilly's oral GLP-1 Foundayo has been recommended for weight reduction and type 2 diabetes in the EU, plus other CHMP decisions.
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA clears Roche’s Enspryng for thyroid eye disease
Roche has claimed US approval for Enspryng in a second indication, thyroid eye disease, that makes it a rival to drugs from Amgen and Viridian.
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Regulatory Intelligence & Drug Approvals3 weeks agoRevMed nears EU okay for pancreatic cancer drug Rasonque
Revolution Medicines is just weeks away from getting EU approval for its keenly anticipated oral RAS drug Rasonque for pancreatic cancer.
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA signals intent to improve consistency, seek external advice on rare disease therapies
BIOCENTURY | REGULATIONFDA SIGNALS INTENT TO IMPROVE CONSISTENCY, SEEK EXTERNAL ADVICE ON RARE DISEASE THERAPIES‘Catastrophically broken’ agency could struggle to implement reforms, former Acting Commissioner Woodcock...
RNA-protein interactions could lead to new coronavirus drug targets
A CRISPR gene boost reduces seizures and strengthens muscles in mice
Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
