Regulatory

Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

Johnson & Johnson’s Tremfya Receives the EC’s Approval for Active Ulcerative Colitis (UC)

Shots: The EC has approved Tremfya to treat mod. to sev. active UC adults with ina...

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Shots: The US FDA has granted 510(k) clearance to PeriCross for controlled & e...

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemci...

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Shots: The US FDA has received BLA for TrenibotE (botulinum neurotoxin serotype E)...

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Shots: The US FDA has granted IND clearance to ATI-052 for the initiation of P-Ia/...

Merck’s Keytruda Regimen Receives Health Canada’s Approval for Malignant Pleural Mesothelioma (MPM)

Merck’s Keytruda Regimen Receives Health Canada’s Approval for Malignant Pleural Mesothelioma (MPM)

Shots: Health Canada has approved Keytruda + pemetrexed + Pt-based CT as 1L treatm...

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