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

pneumococcal

- PMLiVE

Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

- 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

Merck & Co withdraws Keytruda’s US approval in third-line stomach cancer

The FDA initially approved Keytruda in 2017 for stomach cancer based on overall response rate data

- PMLiVE

Positive results for AZ, Merck & Co’s Lynparza in early breast cancer presented at ASCO

Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% in the overall trial population

- PMLiVE

Merck & Co spinoff Organon launches with the aim of ‘improving health outcomes for women’

Merck & Co – known as MSD outside the US and Canada – announced its plans for the women’s health spinoff company last month

- PMLiVE

New trial data for Keytruda in triple-negative breast cancer

Keytruda plus chemotherapy showed significant and meaningful improvement

- PMLiVE

FDA approval for Keytruda/Herceptin combination in first-line advanced gastric cancer

Approval is based on positive overall response rate (ORR) data from KEYNOTE-811 trial

- PMLiVE

Merck & Co reveals plans for women’s health spinoff Organon

Company is expecting tax-free dividend of $9bn following close of spinoff

- PMLiVE

Merck & Co halts development of potential COVID-19 drug MK-7110

Pharma company has abandoned drug due to technical, clinical and regulatory uncertainties

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links