2021 Biological License Application Approvals

Approved New Drug and Biologics License Applications

We conducted a systematic review of publicly available FDA approval documents from January 2019 to June 2021. We sought to quantify, by year,.

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative ...

US FDA CDER New Drug Approvals 2021 - PharmaBoardroom

... Biologics Evaluation and Research (CBER) approved in 2021. Made with Visme ... US FDA CBER Biological License Application Approvals 2022. Latest Report.

Janssen Submits Biologics License Application to U.S. FDA Seeking ...

In January 2021 and June 2021, teclistamab received a PRIority ... approvals; uncertainty of commercial success; manufacturing ...

FDA Accepts Biogen's Aducanumab Biologics License Application ...

The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA ...

Trends and Perspectives of Biological Drug Approvals by the FDA

... Biological Drug Approvals by the FDA: A Review from 2015 to 2021 ... All product references cited in this work hold a Biologics License Application (BLA) number.

21 CFR 601.2 -- Applications for biologics licenses - eCFR

(f) Withdrawal from sale of approved biological products. A holder of a biologics license application (BLA) must report to FDA, in accordance with the ...

42 USC 262: Regulation of biological products - U.S. Code

-Upon approval of an application described in clause (i), such approved application shall be deemed to be a license for the biological product under section 351 ...

Seres Therapeutics Announces FDA Acceptance of Biologics ...

Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. ... In July 2021 ...

Gilead Submits Biologics License Application to U.S. Food and Drug ...

... -- If Approved, Bulevirtide Will Be the First Treatment Option for Adult Patients in the U. S. With Chronic Hepatitis Delta Virus Infection With ...

Biologics License Approval (BLA) & Submissions

A biologics license application applies to vaccines and other allergenic drug products, blood products, and cellular and genetic therapies.

U.S. Food and Drug Administration Accepts for Priority Review ...

... Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of ...

Biologics License Application for Narsoplimab in HSCT-TMA ...

The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its ...

FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb ...

The US Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (US brand name: ...

... application for market approval of a drug. The ... Alvotech USA “is the applicant for FDA biologics license application ('BLA') No.

Licensed Veterinary Biological Product Information

Implementation will continue through 2021. Product licensing efficacy and safety data will be available on the website within 30 days of ...

Proposed Collection; Comment Request; Biologics License ...

Form FDA 2253 is a fillable PDF form and is approved for use in OMB control number 0910-0001; however, in this information collection we account ...

... Biologics License Application for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, Comirnaty, in individuals 16 ...

bluebird bio Submits Biologics License Application (BLA) to FDA for ...

21, 2021-- bluebird bio, Inc. (Nasdaq: BLUE) today announced it has ... If approved, beti-cel will be the first hematopoietic (blood) ...

FDA Issues a Final Rule on Biologics License Applications ...

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (DMF) in Biologics License Applications.