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

Praluent

regeneron headquarters

Regeneron’s Veopoz granted FDA approval for ultra-rare immune disease

Fewer than ten patients in the US have been diagnosed with CHAPLE disease

- PMLiVE

Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

The drug is the first-ever treatment approved in the US for patients with the disease

- PMLiVE

Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

The therapy showed an overall response rate of more than 70% in a broad range of patients

- PMLiVE

Roche’s Genentech and Blueprint receive full FDA approval for Gavreto in lung cancer

The targeted therapy was granted accelerated approval for the NSCLC indication in 2020

- PMLiVE

FDA approves Taiho’s stronger Lonsurf regimen for metastatic colorectal cancer

The approval comes almost eight years after the regulator approved Lonsurf as a monotherapy for the same indication

- PMLiVE

GSK’s Jemperli combination receives FDA approval for endometrial cancer

Approximately 60,000 new cases of endometrial cancer are diagnosed every year in the US

- PMLiVE

FDA approves second over-the-counter naloxone nasal spray for opioid overdose

Over 105,000 fatal opioid overdoses were reported in the US between 2022 and 2023

- PMLiVE

Gilead’s COVID-19 treatment approved by FDA for patients with severe renal impairment

Use of Veklury among this patient population has previously been limited

Biogen Idec building

Biogen/Eisai’s Alzheimer’s disease drug granted full FDA approval

Leqembi was granted accelerated approval earlier this year for patients with early Alzheimer's disease

- PMLiVE

FDA declines to approve Amneal Pharmaceuticals’ Parkinson’s disease treatment

The regulator said the safety for one of the drug's ingredients had not been adequately established

- PMLiVE

FDA approves BioMarin’s Roctavian as first gene therapy for severe haemophilia A

Approximately 2,500 patients are expected to be eligible to receive the one-time therapy

- PMLiVE

FDA approves CellTrans’ Lantidra as first cellular therapy to treat type 1 diabetes

The therapy is indicated for use in patients who are unable to meet their target blood glucose levels

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links