FDA Approval Immune Response Licensing Protein 
XTalks
MAY 1, 2023
Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.
XTalks
APRIL 26, 2021
Related: After 18 Years, FDA Approves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. At six months, 29.5
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XTalks
MAY 2, 2024
In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.
Pfizer
JULY 26, 2022
Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.
The Pharma Data
JUNE 18, 2021
Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.
XTalks
SEPTEMBER 17, 2020
Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. What Is a Surrogate Endpoint?
The Pharma Data
DECEMBER 29, 2020
The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. Casirivimab and imdevimab injection is not FDA approved for any use.
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