Regulatory
Track how regulatory decisions alter competitive positioning, launch timelines, and investor expectations across therapeutic areas.
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REGULATORY
Aficamten has received approval from the MHRA and a recommendation from NICE for use in patients with a serious heart condition.
REGULATORY
The MHRA emphasizes the importance of safe usage of GLP-1 medicines amid rising demand for weight-loss solutions.
REGULATORY
Domperidone products now include a contraindication for patients with confirmed or suspected phaeochromocytoma due to severe hypertension risk.
REGULATORY
The MHRA has approved the world's first lower-carbon beclometasone inhalers, utilizing a next-generation propellant.
REGULATORY
A manufacturing defect has been reported for Xaggitin XL Prolonged-release Tablets, affecting tablet counts in multiple batches.
REGULATORY
Teva UK Limited has identified a labelling error on the Ponlimsi (Denosumab) carton, incorrectly stating 'For application to the skin'.
REGULATORY
Resmetirom (Rezdiffra) has been authorized for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults.
REGULATORY
The MHRA has issued updated safety warnings for botulinum toxin type A products due to rare cases of botulism.
REGULATORY
Iatrogenic botulism cases have been reported following the use of botulinum toxin type A products, indicating a risk of toxin effects extending beyond treatment areas.
REGULATORY
Crescent Pharma Limited is recalling Ramipril 2.5mg capsules due to a packaging error that may lead to patients receiving the incorrect dosage.
REGULATORY
The Allurion Gastric Balloon may cause serious complications, including gastric outlet obstruction, small bowel obstruction, and gastric perforation.
REGULATORY
Project Orbis is designed to expedite the review and approval process for promising cancer therapies.
REGULATORY
Bristol Laboratories Limited is recalling batch 7124002 of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution due to labeling issues.
REGULATORY
The MHRA has completed a review of five plasma-derived medicinal products regarding their safety related to vCJD risk.
REGULATORY
The MHRA has approved the use of UK-donor plasma for five high-priority plasma-derived medicinal products.
REGULATORY
Nerandomilast has received approval from the MHRA for the treatment of adult patients with idiopathic and progressive pulmonary fibrosis.
REGULATORY
Using an IV infusion giving set instead of a blood transfusion giving set poses a risk of serious harm to patients.
REGULATORY
Semaglutide injection has received approval for the treatment of metabolic-associated steatohepatitis in adults with moderate-to-advanced liver fibrosis.
REGULATORY
A discrepancy has been identified in the Patient Information Leaflet for Loperamide hydrochloride 2 mg Orodispersible Tablets.
REGULATORY
The MHRA has authorized a new intravesical delivery system for gemcitabine aimed at adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer.
REGULATORY
Flamingo Pharma UK Ltd has recalled certain packs of Flucloxacillin Capsules BP 500mg due to containing the incorrect patient information leaflet for Amoxicillin.
REGULATORY
Brancaster Pharma Limited reported that certain batches of Benzylpenicillin benzathine were released with an outdated Patient Information Leaflet.
REGULATORY
A Class 4 Medicines Defect Notification has been issued for Hiprex 1g tablets due to an error in Braille embossing on packaging.
REGULATORY
Sandoz Ltd. reported that the Patient Information Leaflet for certain batches of Apixaban tablets lacks up-to-date information.
REGULATORY
Quadrant Pharmaceuticals has reported Class 4 Medicines Defect due to incorrect barcode/GTIN on Vesomni tablets.
Showing 1–25 of 39 records