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FDA Releases SARS-CoV-2 Reference Grade Sequence Data americanpharmaceuticalreview
April 03, 2020
On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. The President of the United States declared a national emergency on March 13, 2020, in response to the COVID-19 outbreak in the United States.
US FDA calls for removal of all ranitidine products expresspharma
April 03, 2020
New studies show NDMA impurity increases in some meds over time, and when stored at higher than room temperature。
FDA and EMA offer updates on COVID-19 treatments and vaccines in development europeanpharmaceuticalreview
April 02, 2020
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
FDA launches new programme to speed-up Covid-19 therapies pharmaceutical-technology
April 02, 2020
The US Food and Drug Administration (FDA) has launched a new programme aimed at accelerating the development of potential treatments for Covid-19 infection.
FDA approves Imfinzi for extensive-stage SCLC pharmatimes
April 01, 2020
AstraZeneca has announced that Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) as 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).
FDA approves Lilly’s plaque psoriasis drug Taltz for children pharmaceutical-technology
April 01, 2020
The US Food and Drug Administration (FDA) has approved Eli Lilly’s Taltz (ixekizumab) to treat moderate to severe plaque psoriasis in children aged six to below 18 years.
Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from US FDA expresspharma
April 01, 2020
The Inspection has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020.
FDA Announces Funding Opportunity for Real-World Data Research americanpharmaceuticalreview
March 31, 2020
The U.S. Food and Drug Administration (FDA) is announcing a funding opportunity for projects to support the agency’s understanding of the potential use of real-world data (RWD) to generate real-world evidence (RWE).
FDA Grants VERO Biotech Expanded Access Emergency Use of GENOSYL DS for COVID-19 Patients americanpharmaceuticalreview
March 31, 2020
VERO Biotech announced the U.S. Food and Drug Administration (FDA) has granted "expanded access emergency use".
FDA Issues Emergency Approval for Anti-Malaria Drugs contractpharma
March 31, 2020
HHS accepts donations of hydroxychloroquine sulfate, chloroquine phosphate as possible treatments for COVID-19 patients.

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