Pharmafile Logo

Monkeypox

- PMLiVE

AstraZeneca and Daiichi Sankyo receive FDA approval for lung cancer drug

A phase 2 trial demonstrated an overall response rate of 57.7% in patients with non-small cell lung cancer

- PMLiVE

Roche’s Xofluza issued FDA approval to treat influenza in children aged five years and older

It is the first and only single-dose oral medicine for this indication in children as young as five

- PMLiVE

Sanofi halts recruitment for trials assessing MS treatment

The pause in enrolment follows advice issued by the Independent Data Monitoring Committee

- PMLiVE

FDA approves Bot Image’s AI software for the detection and diagnosis of prostate cancer

ProstateID combines artificial intelligence with traditional MRI scanning to significantly improve radiologic interpretation accuracy

- PMLiVE

AstraZeneca and Daiichi Sankyo get FDA approval for breast cancer drug

Results from a phase 3 trial showed Enhertu reduced the risk of disease progression or death by 50%

Bayer symbol

Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy

- PMLiVE

Janssen’s Stelara approved by FDA for psoriatic arthritis in paediatric patients

Active psoriatic arthritis affects 5-8% of children and adolescents with chronic inflammatory arthritis

- PMLiVE

Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

Zoryve is the first and only PDE4 inhibitor approved for plaque psoriasis

- PMLiVE

Sarepta to submit application for Duchenne muscular dystrophy gene therapy

The condition occurs in approximately one in every 3,500-5,000 newborn males worldwide

- PMLiVE

FDA grants priority review to Biogen’s tofersen for genetic form of ALS

The approval follows a failed phase 3 study, but the treatment showed promise in patients with SOD1-ALS

- PMLiVE

Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

- PMLiVE

FDA approves Incyte’s Opzelura for vitiligo

It is the first and only FDA-approved product for repigmentation in patients with nonsegmental vitiligo

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links