Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…

ByPrince GiriDecember 23, 2025

NEWS

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

ByRidhi RastogiNovember 26, 2025

NEWS

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for Advanced HER2-mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in…

ByRidhi RastogiNovember 21, 2025

NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

ByRidhi RastogiAugust 11, 2025

NEWS

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Shots: The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing In…

ByRidhi RastogiJuly 3, 2025

NEWS

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…

ByRidhi RastogiMay 16, 2025

NEWS

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…

ByDipanshu DixitApril 3, 2025

INSIGHTS+

The US FDA New Drug Approvals in November 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024 The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…

ByDipanshu DixitDecember 10, 2024

NEWS

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

Shots: The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to…

ByDipanshu DixitDecember 4, 2024

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…

ByDipanshu DixitAugust 14, 2024

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for Advanced HER2-mutant NSCLC

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

The US FDA New Drug Approvals in November 2024

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

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

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