Regulatory

Nurix Therapeutics’ NX-5948 Secures the EMA’s PRIME Designation for Treating R/R Chronic Lymphocytic Leukemia

Nurix Therapeutics’ NX-5948 Secures the EMA’s PRIME Designation for Treating R/R Chronic Lymphocytic Leukemia

Shots: The EMA has granted PRIME designation to NX-5948 for adults with r/r chroni...

UCB’s Bimzelx (Bimekizumab-bkzx) Secures the US FDA’s Approval for Treating Moderate to Severe Hidradenitis Suppurativa (HS)

UCB’s Bimzelx (Bimekizumab-bkzx) Secures the US FDA’s Approval for Treating Moderate to Severe Hidradenitis Suppurativa (HS)

Shots: The US FDA has granted approval to Bimzelx (IL-17F & IL-17A inhibitor)...

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary...

Shots: The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based...

Sangamo Therapeutics Receives the US FDA’s IND Approval for ST-503 to Treat Idiopathic Small Fiber Neuropathy

Sangamo Therapeutics Receives the US FDA’s IND Approval for ST-503 to Treat Idiopathic Small Fiber Neuropathy

Shots: The US FDA has cleared IND application of ST-503 to initiate its P-I/II cli...

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Shots: The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to preven...

AstraZeneca Reports the CHMP’s Positive Opinion of Tagrisso (Osimertinib) for Treating Unresectable EGFR-Mutated Lung Cancer

AstraZeneca Reports the CHMP’s Positive Opinion of Tagrisso (Osimertinib) for Treating Unresectable EGFR-Mutated Lung Cancer

Shots: The CHMP has issued positive opinion for Tagrisso as a treatment of locally...

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