Regulatory

Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old

Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old

Shots: The US FDA has approved the indication expansion of Imcivree to add childre...

BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal...

Shots: The EC has approved Opdivo + Yervoy as a 1L treatment of MSI-H/dMMR unresec...

Pfizer’s Braftovi (Encorafenib) Secures the US FDA’s Accelerated Approval as a 1L Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

Pfizer’s Braftovi (Encorafenib) Secures the US FDA’s Accelerated Approval as a 1L Treatment of BRAF V600E-Mutant Metastatic Colore...

Shots: The US FDA has granted accelerated approval to Braftovi + cetuximab & m...

Eli Lilly Reports the US FDA’s Approval of Zepbound (Tirzepatide) to Treat Moderate-to-Severe Obstructive Sleep Apnea in Obese Adults

Eli Lilly Reports the US FDA’s Approval of Zepbound (Tirzepatide) to Treat Moderate-to-Severe Obstructive Sleep Apnea in Obese Adu...

Shots: The US FDA has granted approval to Zepbound for treating moderate-to-severe...

Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara)

Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara)

Shots: Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Jan...

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