Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…

ByRidhi RastogiFebruary 12, 2025

NEWS

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Shots: The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25 Application was backed by the development program of…

ByRidhi RastogiFebruary 11, 2025

NEWS

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Shots: The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25 The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…

ByDipanshu DixitJanuary 30, 2025

NEWS

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

NEWS

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Shots: Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024 The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…

ByDipanshu DixitDecember 31, 2024

NEWS

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Shots: Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…

ByDipanshu DixitOctober 11, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Shots: The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab) Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …

ByDipanshu DixitJuly 22, 2024

NEWS

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab) The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference FKS518 is indicated for…

ByDipanshu DixitMay 27, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in January 2024

Shots: The US FDA approved 1 NDA in January 2024, leading to treatments for patients and advances in the healthcare industry In January 2023, Zelsuvmi was approved by the US FDA for the Treatment of Molluscum Contagiosum PharmaShots has compiled a list of US FDA-approved drugs in the month January 2024 1. Ligand Pharmaceuticals’ Zelsuvmi Receives…

BySenior EditorFebruary 8, 2024

VIEWPOINTS

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

Shots: Björn Mellgård Vice President and Global Program Lead, TTP Program, Takeda, shares insights from the P-III data of TAK-755 for the treatment of cTTP Björn eloquently shares the highlights of the study design for TAK-755, safety and efficacy outcomes, and goes on to share an update from the P-IIIb continuation trial evaluating TAK-755 With…

BySaurabh ChaubeyOctober 19, 2023

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

Insights+: The US FDA New Drug Approvals in January 2024

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

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