The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc.

FDA 40

FDA Treatment Small Molecule Drugs 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40

Drug Target Review

MARCH 20, 2025

While the AZALEA trial primarily focused on safety, with efficacy data anticipated from the ongoing LILAC trial conducted by Anthos Therapeutics, the observed reductions in major and gastrointestinal (GI) bleeding are significant. Eliquis, Xarelto) which prevent abnormal blood clots at the expense of an increase in bleeding risk.

Therapies 52

Therapies Trials Clinical Development FDA 52

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. 7) BNT162b2 has not been approved or licensed by the U.S. In February 2021, Pfizer announced that the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40