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

patisiran

- PMLiVE

Gilead’s Trodelvy granted FDA priority review for metastatic breast cancer

Phase 2 study results showed a 34% reduction in risk of disease progression or death

- PMLiVE

GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants

4.2% of the cases of pertussis reported in the US in 2021 were in infants younger than six months

- PMLiVE

FDA approves scPharmaceuticals’ on-body infusor for congestive heart failure

The at-home device delivers the equivalent of what a patient would receive by way of IV

- PMLiVE

Alnylam’s RNAi therapeutic expanded by FDA in advanced primary hyperoxaluria type 1

A phase 3 trial showed Oxlumo treatment resulted in substantial reductions in plasma oxalate

- PMLiVE

Alnylam discovers mutations in stomach fat gene that could protect against abdominal obesity

The findings support the potential for the INHBE gene to be evaluated as a novel therapeutic target for the treatment of cardiometabolic disease

- 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 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

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links