2018, Biosimilars, Small Molecule and Vaccine

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range.

FDA

FDA Biosimilars Science Production

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

APRIL 7, 2023

About BRAFTOVI + MEKTOVI BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK).

FDA

FDA FDA Approval Small Molecule Drugs

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine

Vaccine Production FDA FDA Approval

Drug Discovery Digest

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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