Approvals

IMFINZI (durvalumab) approved in the US for extensive-stage small cell lung cancer

AstraZeneca announced that IMFINZI (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide).

FDA approves Bristol Myers Squibb’s ZEPOSIA oral treatment for relapsing forms of multiple sclerosis

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) approved ZEPOSIA (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

ViiV Healthcare secures Canadian approval for HIV drug regimen CABENUVA

ViiV Healthcare has secured approval for CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions) from Health Canada for the treatment of HIV-1 infection in adults.

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.