Approvals

Novartis receives Japanese approval for Zolgensma in spinal muscular atrophy

Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA) in patients under the age of two, including those who are pre-symptomatic at diagnosis. Patients must be negative for elevated anti-AAV9 antibodies.

FDA approves new treatment for paediatric patients with any strain of Hepatitis C

The US Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis.

Dicerna receives orphan drug designation from FDA for DCR-A1AT to treat alpha-1 antitrypsin deficiency

Dicerna Pharmaceuticals, a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Dicerna’s DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency.

Lilly, Incyte get FDA breakthrough therapy status for baricitinib to treat alopecia areata

Eli Lilly and Incyte have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for baricitinib to treat alopecia areata (AA).

Boehringer, Eli Lilly get FDA fast track status for Jardiance to treat chronic kidney disease

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 gets FDA nod for Opdivo + Yervoy to treat liver cancer

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.

Janssen gets FDA breakthrough therapy status for JNJ-6372 to treat metastatic NSCLC

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).

Novartis gets FDA nod for Isturisa to treat Cushing’s disease

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.

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.