Drug Filing

EMA grants orphan drug designation to AlloVir’s Viralym-M

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 gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer

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 initiates rolling submission of a new drug application to the FDA for Voclosporin in the treatment of lupus nephritis

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 announces US FDA acceptance of NDA for Vibegron to treat overactive bladder

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.

EMA’s CHMP recommends approval for Boehringer’s nintedanib to treat SSc-ILD

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 receives FDA IND approval for phase 2 trial and orphan drug designation for HBM9167

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).

GSK, Innoviva seek EMA approval for Trelegy Ellipta to treat asthma in adults

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.

FDA advisory committee votes in favour of Lilly’s CYRAMZA as first-line treatment for metastatic EGFR-mutated NSCLC

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.

Takeda’s ALUNBRIG gets FDA priority review for expanded indication in NSCLC

Takeda Pharmaceutical has secured priority review for ALUNBRIG (brigatinib) from the US Food and Drug Administration (FDA) for its expanded use as a first-line treatment for a type of non-small cell lung cancer (NSCLC).