Regulatory | 05 June 2025
UK MHRA approves aumolertinib to treat non-small cell lung cancer
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Allopurinol is used to prevent or lower high uric acid levels in the blood
Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,
These observations are procedural in nature and none of them are related to data integrity
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