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

osteoporosis

- PMLiVE

Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for non-Hodgkin lymphomas

About 20,700 new cases of chronic lymphocytic leukaemia are expected to be diagnosed in the US this year

- PMLiVE

BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

More than two-thirds of patients have advanced or metastatic disease at the time of diagnosis

- PMLiVE

FDA approves Mirum’s Livmarli to treat cholestatic pruritus in rare liver disease patients

Progressive familial intrahepatic cholestasis affects one in every 50,000 to 100,000 births in the US and Europe

regeneron headquarters

Regeneron’s Praluent receives FDA approval for paediatric patients with genetic high cholesterol

Patients aged eight year or older with heterozygous familial hypercholesterolaemia will be eligible to receive the treatment

- PMLiVE

Bristol Myers Squibb’s Opdivo combination receives FDA approval for urothelial carcinoma

More than 83,000 news cases of bladder cancer are expected to be diagnosed in the US this year

- PMLiVE

BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

Approximately 15,000 new cases of follicular lymphoma are diagnosed in the US every year

- PMLiVE

Sandoz receives FDA approval for first denosumab biosimilars Wyost and Jubbonti

The biosimilars have been authorised for all indications covered by Amgen's reference medicines

- PMLiVE

Johnson & Johnson’s Rybrevant granted FDA approval for lung cancer indications

The drug was previously authorised for use by the US regulator under the accelerated approval pathway

- PMLiVE

FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

- PMLiVE

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

- PMLiVE

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

- PMLiVE

Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

More than 35,000 cases of the blood cancer are expected to be diagnosed in the US this year

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links