FDA approves oral formulation of treatment for amyotrophic lateral sclerosis

12 May 2022 - Today, FDA approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis.  ...

Read more →

FDA’s Pazdur challenges attack on accelerated approval program

2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...

Read more →

Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL

10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...

Read more →

Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease

12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...

Read more →

US FDA grants rare paediatric disease designation to paxalisib for DIPG

7 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has awarded rare paediatric disease designation ...

Read more →

FDA's drug approval system is more open than Australia's

11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies. ...

Read more →

FDA track: PDUFA Performance

5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User ...

Read more →

FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

Read more →

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence.  ...

Read more →

Verastem expands duvelisib development program to include peripheral T-cell lymphoma

6 Septemner 2017 - Duvelisib receives fast track designation from FDA in peripheral T-cell lymphoma; company to initiate a phase 2 ...

Read more →

American patients can access far more new cancer drugs than others can

13 February 2017 - New research by scholars at the University of Pittsburgh shows that American patients have significantly better access ...

Read more →