Bristol Myers Squibb and bluebird bio submitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adults with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Roche announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza (baloxavir marboxil).
AlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, announced it has been granted Orphan Drug Designation from the European Medicines Agency (EMA) for Viralym-M (ALVR105) as a potential treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplantation (HSCT).
Infinity Pharmaceuticals said that IPI-549 in combination with nivolumab (Opdivo) has been given the fast track designation from the US Food and Drug Administration (FDA) for the treatment of advanced urothelial cancer.
Aurinia Pharmaceuticals has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis (“LN”).
Urovant Sciences announced that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The European Medicines Agency’s (EMA) Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Boehringer Ingelheim’ nintedanib to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adult patients.
Harbour BioMed (HBM) announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC).
British drugmaker GlaxoSmithKline (GSK) and Innoviva are seeking approval from the European Medicines Agency (EMA) for an additional indication of Trelegy Ellipta to treat adult patients with asthma.
Eli Lilly and Company announced that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 6-5 that CYRAMZA (ramucirumab) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC), based on the results of the positive Phase 3 RELAY study.
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