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Regulatory Intelligence & Drug Approvals2 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 Approvals2 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...
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Regulatory Intelligence & Drug Approvals2 weeks ago10 Day Forecast may be harmful due to hidden ingredients
The FDA is advising consumers not to purchase or use 10 Day Forecast, a product promoted and sold for sexual enhancement on various websites, including ebay.com,...
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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’s latest rare disease framework seeks to prioritize consistency in flexibility
Following several recent initiatives, the FDA's newest rare disease framework sets out to standardize the agency's approach to scientific evidence and bring rare disease therapies to...
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Regulatory Intelligence & Drug Approvals3 weeks agoAdvancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs – 08/27/2026
This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of...
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Regulatory Intelligence & Drug Approvals3 weeks agoSTAT+: Pharmalittle: We’re reading about former FDA head calling DOGE a ‘disaster,’ an AstraZeneca AI deal, and more
Three former FDA chiefs lit into the Trump administration, criticizing the now former FDA officials who oversaw a massive staff exodus
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Regulatory Intelligence & Drug Approvals3 weeks agoImmunityBio bags elusive label extension for Anktiva
The FDA has handed ImmunityBio a key label extension for bladder cancer therapy Anktiva, giving it a leg-up on rival drug Inlexzo from J&J.
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Regulatory Intelligence & Drug Approvals3 weeks agoCompass Pathways CEO: Psychedelics company will ‘go slow before we go fast’
The CEO of Compass Pathways said the company, whose psychedelic therapy is set for regulatory review this year, is prepared to “go slow before we go...
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Regulatory Intelligence & Drug Approvals3 weeks agoRare Disease Framework
Rare Disease Regulatory Framework
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
