Sygnature Discovery

NOVEMBER 29, 2023

Over 50,000 people will die of pancreatic cancer in the USA in 2023 (American Cancer Society estimate) and over 9,000 people in the UK. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Sygnature Discovery

NOVEMBER 29, 2023

Over 50,000 people will die of pancreatic cancer in the USA in 2023 (American Cancer Society estimate) and over 9,000 people in the UK. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA 40

FDA Production Licensing Licensing 40

Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

FDA 40

FDA Science Biosimilars Production 40