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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Rare Disease Framework Initiative Public Meeting – 10/28/2026
On October 28, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with...
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Regulatory Intelligence & Drug Approvals3 weeks agoVerastem reports ‘robust’ response rate in pancreatic cancer subgroup where Rasonque struggled
Revolution Medicines’ recently approved drug showed a 24% overall response rate and a high rate of side effects in patients whose cancer has a G12D mutation,...
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Regulatory Intelligence & Drug Approvals3 weeks agoSTAT+: FDA adcomm members’ ties to industry under scrutiny
New research found that nearly 40% of FDA advisory meetings held over a recent 20-year period included either a patient or consumer rep with active ties...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA new drug approvals in Q3 2026
Nature Reviews Drug Discovery, Published online: 14 October 2026; doi:10.1038/d41573-026-00164-9FDA new drug approvals in Q3 2026
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Regulatory Intelligence & Drug Approvals3 weeks agoHelp More Providers Prescribe with Confidence
Partner with the FDA’s Center for Drug Evaluation and Research to encourage providers to manage opioid use disorder with MOUD.
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Regulatory Intelligence & Drug Approvals3 weeks agoPar Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the...
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Regulatory Intelligence & Drug Approvals3 weeks agoConvenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
Acumen Pharmaceuticals Announces Topline Results from Phase 2 ALTITUDE-AD Clinical Trial of Sabirnetug (ACU193) for the Treatment of Early Alzheimer’s Disease; Trial Did Not Meet Primary Endpoint
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
