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Regulatory Intelligence & Drug Approvals2 months agoFDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development
Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.
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Regulatory Intelligence & Drug Approvals2 months ago3 KRAS drugs to watch as the field expands
Revolution’s pancreatic cancer approval marked a milestone in RAS-targeted treatment. Now, new treatments from Revolution, Astellas and Genentech could be the next to make a mark...
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Regulatory Intelligence & Drug Approvals2 months agoFDA to decide on Takeda’s psoriasis blockbuster hope in Q1
The FDA has started a review of the marketing application for Takeda's TYK2 inhibitor zasocitinib in psoriasis, setting up a decision in mid-March.
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Regulatory Intelligence & Drug Approvals2 months agoFDA reduces monitoring time for Amgen’s Imdelltra infusions
The revised guidance is intended for adults whose ES-SCLC has progressed after treatment with platinum-based chemotherapy. It recommends a monitoring period ranging between six and eight...
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Regulatory Intelligence & Drug Approvals2 months agoFDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera
The FDA has approved the industry’s first radioligand equivalent in Curium’s lutetium Lu 177 dotatate injection, Bexlutry, after a court cleared the Boston company of all...
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Regulatory Intelligence & Drug Approvals2 months agoEsophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
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Regulatory Intelligence & Drug Approvals2 months agoPsychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast
BIOCENTURY | REGULATIONPSYCHEDELICS AT FDA, MIKE DAVIS’ CDER AND TRANSLATING TRNAS — A BIOCENTURY PODCAST FDA could approve psychedelics before redosing is resolved. Plus: Takeaways from first...
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Reduced Monitoring Time for First Two Doses of Imdelltra
THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Imdelltra...
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Regulatory Intelligence & Drug Approvals2 months agoFDA could approve psychedelics before redosing is resolved
BIOCENTURY | REGULATIONFDA COULD APPROVE PSYCHEDELICS BEFORE REDOSING IS RESOLVEDAgency officials say 12-week efficacy could support initial approval while durability and maintenance regimens continue to mature
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Regulatory Intelligence & Drug Approvals2 months ago
Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma
WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of...
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
