Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Avidity Biosciences

- PMLiVE

FDA lifts hold on Gilead’s clinical trials for leukaemia

Following a review of the safety data, enrolment can be resumed for the MDS and AML clinical trials

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

- PMLiVE

FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

Eli Lilly HQ

Lilly invests in antibody oligonucleotides conjugates with Avidity deal

Companies to develop new immonology medicines

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links