The Pharma Data

NOVEMBER 5, 2020

The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50% Oncology Program. 50% PD-L1 expression.

Production 40

Production FDA Trials FDA Approval 40

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

Government 40

Government Vaccine Production Licensing 40

Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40

Codon

FEBRUARY 23, 2025

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Half of the participants received lenacapavir, and the other half an injectable placebo.

Clinical Trials 81

Clinical Trials Virus Vaccine DNA 81