Regulatory

Merck Reports the CHMP’s Positive Opinion of Keytruda Plus Padcev to Treat Unresectable or Metastatic Urothelial Carcinoma

Merck Reports the CHMP’s Positive Opinion of Keytruda Plus Padcev to Treat Unresectable or Metastatic Urothelial Carcinoma

Shots: The CHMP has granted positive opinion to Keytruda + Padcev as a 1L treatmen...

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

Shots: The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inh...

AbbVie’s Skyrizi (Risankizumab) Receives the EC’s Approval to Treat Moderate to Severe Active Ulcerative Colitis

AbbVie’s Skyrizi (Risankizumab) Receives the EC’s Approval to Treat Moderate to Severe Active Ulcerative Colitis

Shots: The EC approved Skyrizi (induction dose: 1,200mg, IV, wks.0, 4 & 8; mai...

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata

Shots: The US FDA has granted approval to the company’s Leqselvi (8mg) table...

Pfizer Reports the EC’s Conditional Approval of Durveqtix (Fidanacogene Elaparvovec) for the Treatment of Hemophilia B

Pfizer Reports the EC’s Conditional Approval of Durveqtix (Fidanacogene Elaparvovec) for the Treatment of Hemophilia B

Shots: The EC has granted conditional marketing authorization to Durveqtix in seve...

ConSynance Therapeutics’ CSTI-500 Receives the US FDA’s Rare Pediatric Disease Designation to Treat Prader-Willi Syndrome

ConSynance Therapeutics’ CSTI-500 Receives the US FDA’s Rare Pediatric Disease Designation to Treat Prader-Willi Syndrome

Shots: The US FDA has granted rare pediatric disease designation (RPDD) to the com...

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