Regulation

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.

Zydus secures DCGI approval for Saroglitazar to treat liver disease

India-based pharmaceutical firm Zydus Cadila said that its new drug application (NDA) for Saroglitazar has been approved by the Drug Controller General of India (DCGI) to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) in India.

Alnylam gets EC nod for Givlaari to treat acute hepatic porphyria

Alnylam Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for its Givlaari (givosiran) to treat acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

FDA approves GSK’s Advil Dual Action with Acetaminophen OTC pain reliever

GlaxoSmithKline (GSK) has secured approval for Advil Dual Action with Acetaminophen from the US Food and Drug Administration (FDA) as an over-the-counter (OTC) product for pain relief.

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.

Lysogene receives FDA fast track designation for LYS-SAF302 gene therapy in MPS IIIA

Lysogene, a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).