Boehringer Ingelheim and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for the investigation of Jardiance (empagliflozin) to treat chronic kidney disease.
Bristol Myers Squibb (BMS) has secured approval from the US Food and Drug Administration (FDA) for Opdivo (nivolumab) 1mg/kg plus Yervoy (ipilimumab) 3 mg/kg to treat patients with hepatocellular carcinoma (HCC) earlier treated with sorafenib.
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC).
AbbVie said that the European Commission has approved a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Isturisa (osilodrostat) oral tablets to treat adults with Cushing’s disease.
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.
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 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.
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.
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.
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