Dr. Reddy’s Laboratories Ltd. along with the company’s subsidiaries announced that Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules, was approved by Health Canada and launched in the Canadian market.
The U.S. Food and Drug Administration on May 19 authorized storage of Pfizer Inc. and German partner BioNTech SE’s Covid-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available.
AstraZeneca released primary analysis showing that the company’s AZD1222 vaccine demonstrated 76 percent efficacy against symptomatic Covid-19, 100 percent efficacy against severe or critical disease and hospitalizations, and 85 percent efficacy against symptomatic Covid-19 in people 65 years and older.
Newly announced findings from a Phase III trial conducted by CytoDyn indicate that the use of the late-stage biotechnology company’s CCR5 antagonist candidate Vyrologix (leronlimab) was safe and improved the survival rate in critically ill hospitalized patients with coronavirus disease 2019.
Health Canada on Dec. 9 approved the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, clearing the way for shots to be delivered and administered across the country.
Economic relief and a vaccine drew nearer to reality to counter a coronavirus pandemic that has ravaged the U.S. economy and killed 286,487 people with year-end holiday gatherings expected to fuel another surge in infections.
If all things go well, the Pfizer-BioNTech Covid-19 vaccine will receive EUA from the U.S. Food and Drug Administration around December 10 or within a few days after, and the Moderna vaccine will receive EUA around December 17 or within a few days after.
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).