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Regulatory Intelligence & Drug Approvals2 months ago2026 DIA/FDA Oligonucleotide-Based Therapeutics Conference – 09/23/2026
The FDA and DIA have expressed a willingness to leverage their combined strengths for the joint development of this conference that will incorporate dialogue between regulators...
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Regulatory Intelligence & Drug Approvals2 months agoPublic Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 09/16/2026
The Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for...
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Regulatory Intelligence & Drug Approvals2 months agoList of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a...
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Regulatory Intelligence & Drug Approvals2 months agoAs ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety
As the FDA marches toward the likely first approval of a psychedelic medicine, the agency today convened a hearing seeking public input on how these drugs...
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Regulatory Intelligence & Drug Approvals2 months ago
As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety
As the FDA marches toward the likely first approval of a psychedelic medicine, the agency today convened a hearing seeking public input on how these drugs...
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Regulatory Intelligence & Drug Approvals2 months agoAstraZeneca’s newly approved pill fails frontline breast cancer study
Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
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Regulatory Intelligence & Drug Approvals2 months agoRISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations – 09/29/2026
This public workshop, co-convened by Duke Margolis and the FDA Rare Disease Innovation Hub, will explore statistical considerations in the design, conduct, and analysis of clinical...
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Regulatory Intelligence & Drug Approvals2 months agoDefinium moves toward FDA submission for LSD drug in anxiety after ‘another clear win’
Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while...
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: Pharmalittle: We’re reading about another AstraZeneca trial failure, a Novo name change, and more
AstraZeneca disclosed that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors
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Regulatory Intelligence & Drug Approvals2 months agoScholar Rock SMA drug approved by FDA
Projected by some analysts as a future blockbuster, Isembyld is the first “muscle-targeted” treatment for the disease and, in clinical testing, helped improve motor function in...
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
