Regulatory

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...

Lantern Pharma's LP-184 Gains the US FDA’s Fast-Track Designation to Treat TNBC

Lantern Pharma's LP-184 Gains the US FDA’s Fast-Track Designation to Treat TNBC

Shots: This designation is based on anti-tumor activity in 10 TNBC PDX models &...

Eli Lilly Reports Kinsula (Donanemab-Azbt) Approval in China to Treat Early Symptomatic Alzheimer's Disease

Eli Lilly Reports Kinsula (Donanemab-Azbt) Approval in China to Treat Early Symptomatic Alzheimer's Disease

Shots: The NMPA has approved Kisunla (donanemab-azbt) based on

GSK’s GSK’227 Secures the EMA’s Priority Medicines (PRIME) Designation for Extensive-Stage Small-cell Lung Cancer

GSK’s GSK’227 Secures the EMA’s Priority Medicines (PRIME) Designation for Extensive-Stage Small-cell Lung Cancer

Shots: The EMA has granted PRIME designation to GSK5764227 (GSK’227 or HS-20...

ViiV Healthcare Reports the CHMP’s Positive Opinion of Vocabria Plus Rekambys for HIV treatment

ViiV Healthcare Reports the CHMP’s Positive Opinion of Vocabria Plus Rekambys for HIV treatment

Shots: ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) h...

Merck Reports the US FDA’s BLA Acceptance of Clesrovimab to Protect Infants from RSV Disease

Merck Reports the US FDA’s BLA Acceptance of Clesrovimab to Protect Infants from RSV Disease

Shots: The US FDA has accepted the BLA of clesrovimab (MK-1654) to protect infants...

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