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Regulatory Intelligence & Drug Approvals2 months agoAstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger market
SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for...
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Regulatory Intelligence & Drug Approvals2 months agoScholar Rock secures first FDA approval for muscle-targeting rare disease drug
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party...
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Regulatory Intelligence & Drug Approvals2 months agoAZ’s Etcamah falls short in first-line breast cancer trial
A week after getting FDA approval for frontline breast cancer treatment, AstraZeneca's Etcamah missed the mark in a trial aiming to expand its label.
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: Definium’s LSD therapy eased anxiety in second large trial
The first wave of biotechs is nearing regulatory approval for psychedelic therapies, a class of treatments that appear to exert rapid benefits.
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Regulatory Intelligence & Drug Approvals2 months agoScholar Rock gets first drug approval as FDA okays Isembyld
Scholar Rock has won its first product approval, on its second attempt, as the FDA gives a green light to its spinal muscular atrophy drug Isembyld.
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Regulatory Intelligence & Drug Approvals2 months agoScholar Rock scores long-awaited FDA approval, the first for muscle loss in SMA
The injectable monoclonal antibody is the first to treat muscle atrophy in patients with SMA, according to the FDA.
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Regulatory Intelligence & Drug Approvals2 months agoPsychedelic therapies ride wave of public favor into FDA hearing
Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these...
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Regulatory Intelligence & Drug Approvals2 months agoAfter a brief storm of political headwinds, mRNA is back with strong momentum
A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the...
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors
Boston, MA – 14 September, 2026 – Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for...
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma
Melbourne (Australia) and Indianapolis, IN (United States) | September 14, 2026 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has...
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
