Delveinsight

DECEMBER 13, 2020

In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir? In August 2017, the US FDA approved glecaprevir/pibrentasvir (Mavyret) to treat adults with HCV genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

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Genotype FDA Approval DNA Drugs 52

The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA.

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Vaccination Vaccine Immune Response FDA Approval 52

The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material.

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Vaccination Vaccine Production Manufacturing 52

Pfizer

NOVEMBER 2, 2022

The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach. The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains.

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Vaccination Vaccine Clinical Trials Clinical Trials 85

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. million in funding to support this work.

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Immune Response Vaccination Vaccine FDA Approval 52

WCG Clinical

MAY 28, 2024

Today there are six CAR-T products with FDA approval for the treatment of multiple myeloma and B cell malignancies, with many related and next-generation products under development. This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection.

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In-Vivo Clinical Trials Clinical Trials FDA Approval 40

The Pharma Data

DECEMBER 31, 2020

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis .

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Vaccination Vaccine FDA Approval Hormones 52

STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines  can be greenlighted.

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