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Gilead gets FDA approval for Epclusa to treat hepatitis C in children pharmaceutical-technology
March 23, 2020
Gilead Sciences has received approval from the US Food and Drug Administration (FDA) to use Epclusa for treating chronic hepatitis C infection (HCV) in children aged six years and above.
State FDA authorities initiate measures to ensure availability of masks and hand sanitisers expresspharma
March 23, 2020
Sikkim, which is facing a shortage of hand sanitisers, has given manufacturing license to three firms, whereas the Gujarat FDCA has asked manufacturers to increase the productions.
FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C fda
March 20, 2020
The U.S. 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
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments prnewswire
March 20, 2020
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic.
Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections fda
March 20, 2020
Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.
Bright Path Labs Accepted into FDA's Emerging Technology Program contractpharma
March 20, 2020
Scalable continuous manufacturing technology paves way for rapid, low-cost domestic API production.
FDA Scales Back Domestic Inspections contractpharma
March 20, 2020
Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.
Janssen seeks FDA approval for ponesimod in MS pharmaceutical-technology
March 20, 2020
Janssen Pharmaceutical has filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ponesimod to treat relapsing multiple sclerosis (MS) in adults.
Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials expresspharma
March 20, 2020
The US Food and Drug Administration has issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
Jardiance bags FDA Fast Track designation pharmatimes
March 19, 2020
The US Food and Drug Administration (FDA) has granted Boehringer Ingelheim Fast Track designation for the investigation of Jardiance (empagliflozin).

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