Teva Pharms' Generic Dextroamp Saccharate Receives Approval in the U.S.
Teva Pharms' Generic Sofosbuvir Receives Approval in the U.S.
insigHT2021, Malaysia's medical travel market intelligence conference, featured the launch of Malaysia as the Hepatitis C Treatment Hub of Asia by Minister of Health Malaysia, Yang Berhormat Khairy Jamaluddin.
The drug price regulator has refused pharma major Cipla Ltd’s application to discontinue four of its formulations to treat Human Immunodeficiency Virus (HIV), noting that it may affect availability of the drugs under the National Aids Control Programme.
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa® (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages 3 years and older is based on weight.
The FDA has approved an expanded use of Gilead Sciences' (NASDAQ:GILD) pediatric indication of Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity.
The European Commission (EC) has expanded marketing authorisation for Gilead's Epclusa (sofosbuvir/velpatasvir/sofosbuvir) to include the treatment of children with chronic hepatitis C infection (HCV).
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced the presentation of more than 40 abstracts reflecting the breadth of research from the company’s programs addressing significant challenges in viral hepatitis, nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) at The Digital International Liver Congress™ 2020 (ILC) from August 27-29.
Existing drugs may help us get through the coronavirus pandemic while we wait for a vaccine, but high pricing by pharmaceutical companies will probably mean that, even if these drugs are proven to be effective, many sick people will still be prevented from getting
Gilead has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for patients as young as six for the treatment of chronic hepatitis C.