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Regulatory Intelligence & Drug Approvals1 month agoFDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
The FDA today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Lilly’s breast cancer combo wins approval
The FDA just approved a new combination drug treatment for patients with an advanced form of breast cancer.
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Regulatory Intelligence & Drug Approvals1 month agoFDA Roundup: June 18, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Regulatory Intelligence & Drug Approvals1 month agoFDA Roundup: July 26, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Regulatory Intelligence & Drug Approvals1 month agoHow J&J paved the way for Compass’ coming psychedelic drug launch
In an interview with BioPharma Dive, Compass executives said that, should the FDA approve their treatment, they hope to capitalize on a strategy pioneered by J&J...
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Regulatory Intelligence & Drug Approvals1 month agoBayer offloads cancer drug Stivarga to Grünenthal for up to $431M as new competition looms
Bayer has decided to offload its aging cancer drug Stivarga to German compatriot Grünenthal as a potential new competitor from Exelixis nears an FDA decision.
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Regulatory Intelligence & Drug Approvals1 month agoCiting Replimune approval, experts say localized cancer meds could redefine care
Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but...
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Regulatory Intelligence & Drug Approvals1 month agoMikhail, Davis on board with regulatory framework tailored to rare disease therapies
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease...
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Regulatory Intelligence & Drug Approvals1 month agoConvenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules
AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Radiopharma companies merge after one receives surprise FDA rejection
ITM Isotope Technologies Munich SE and Telix Pharmaceuticals, two leading companies in the burgeoning radiopharmaceuticals field, are merging.
LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis
Stigmatizing language found in over half of primary care patient records
Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
