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J&J
NEWS

Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations 

Shots:     The US FDA has approved J&J’s Rybrevant + Lazcluze as a 1L treatment for LA/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations  The approval was based on the P-III (MARIPOSA) assessing Rybrevant + lazertinib vs osimertinib and lazertinib alone in 1074 patients  The study reached its 1EP and 2EPs…
August 19, 2024

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Incyte and Syndax
NEWS

Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD) 

Shots:     Based on P-II (AGAVE-201) study, Niktimvo got FDA approval to treat chronic GvHD patients who failed at least two lines of previous therapy  Niktimvo patients (0.3 mg/kg, Q2W, n=79) achieved 75% ORR in 6mos. with 1.5mos. mToR; 60% maintained response at 12mos. Study also met key exploratory EPs, 56% patients achieved ≥7-point improvement in…
August 14, 2024

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Gilead (2)
NEWS

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC) 

Shots:     Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis  The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…
August 14, 2024

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Sandoz
NEWS

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration 

Shots:  The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients  Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…
August 12, 2024

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Ascendis Pharma
NEWS

Ascendis Pharma’s Yorvipath Receives the US FDA’s Approval to Treat Hypoparathyroidism 

Shots:      The US FDA has approved Yorvipath (QD) tablets for treating hypoparathyroidism patients, with its initial supply planned during Q1’25  The approval was supported by the P-II (PaTH Forward) as well as P-III (PaTHway) clinical trials conducted worldwide   Ascendis will further introduce the US Ascendis Signature Access Program (A.S.A.P.) for treatment support & financial assistance…
August 9, 2024

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Servier
NEWS

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:     The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery  Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…
August 6, 2024

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Insights+ Key Biosimilars Events of July 2024
INSIGHTS+

Insights+ Key Biosimilars Events of July 2024

Shots:     Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency      Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients      The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
August 1, 2024

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