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

Embeda

- PMLiVE

FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

AZ and Avillion’s asthma rescue treatment recommended by FDA Advisory Committee

PT027 significantly reduced the risk of severe asthma exacerbations

regeneron headquarters

Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

- PMLiVE

Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation

Elranatamab-treated patients achieved an overall response rate of 61% in a phase 2 trial

- PMLiVE

Pfizer and BioNTech dose first patient in COVID-19/flu combination vaccine study

The vaccine aims to protect individuals against two severe respiratory viral diseases

- PMLiVE

Gilead’s Vemlidy gets FDA approval for paediatric patients with chronic hepatitis B infection

The application was supported by positive 24-week data from a phase 2 trial

- PMLiVE

Pfizer’s maternal RSV vaccine candidate shows promise in phase 3 trial

The company stopped the trial early and plans to file for US approval by the end of 2022

- PMLiVE

GSK’s respiratory syncytial virus older adult vaccine given Priority Review by FDA

There are currently no RSV vaccines approved for older adults anywhere worldwide

- PMLiVE

FDA receives Santhera and ReveraGen’s application for Duchenne muscular dystrophy treatment

The submission includes positive data from the pivotal phase 2b and four open-label studies

- PMLiVE

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

A final decision for daprodustat by the FDA is expected by 1 February 2023

- PMLiVE

Janssen’s Tecvayli granted FDA approval for multiple myeloma

A phase 2 study demonstrated an overall response rate of 61.8% in Tecvayli-treated patients

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links