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Regulatory Intelligence & Drug Approvals1 month agoOncoC4 Receives FDA Fast Track Designation for Cesalatamig, an Investigational PD-1/VEGF Bispecific Antibody
Rockville, MD, September 16, 2026 (PR NEWSWIRE)— OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced that the...
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Regulatory Intelligence & Drug Approvals1 month ago
Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for Ibtrozi (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer
NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer...
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Regulatory Intelligence & Drug Approvals1 month agoJanuary – March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
January - March 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
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Regulatory Intelligence & Drug Approvals1 month agoFDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been...
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Regulatory Intelligence & Drug Approvals1 month agoReporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion in the Aftermath of a Natural Disaster
FDA is aware that pharmaceutical manufacturers and authorized distributors may be contacted by sales representatives concerning drug sample losses in the wake of natural disasters.
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Regulatory Intelligence & Drug Approvals1 month agoSling banks $123M for an experimental thyroid eye disease pill
A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and...
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Regulatory Intelligence & Drug Approvals1 month agoFDA warning letter accuses Bausch & Lomb of lacking commitment to remediation
After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations.
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Regulatory Intelligence & Drug Approvals1 month agoDeep dive: Psychedelics back on FDA’s doorstep
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Sen. Warren demands to see Trump drug-pricing pharma contracts, accuses RFK Jr. of hiding them
An FDA pilot program to speed up drug development, Democrats plan health care probes after midterms, and more biotech news
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Pharmalittle: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more
The FDA is opening applications for a pilot program designed to shorten the time it takes for drugmakers to begin testing their products in humans
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
