Pharma News

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Novartis’ Cosentyx (secukinumab), either alone or with methotrexate, for treatment of...

ICER has published its cost-effectiveness analysis on expensive gene therapies, and Roctavian’s potential use faces more questions than EtranaDez.

Officials with the FDA approved cemiplimab-rwlc (Libtayo; Regeneron) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung...

GSK has revealed updated results from its phase 2b trial of its antisense drug for hepatitis B virus (HBV) infections, which reveal a sharp decline in the proportion of patients with undetectable l...

Teva resubmitted a New Drug Application (NDA) to the FDA for mdc-IRM, a risperidone subcutaneous long-acting injectable for maintenance treatment of schizophrenia, following a Complete Response Let...

Major depressive disorder (MDD) is diagnosed using the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria, which includes symptoms such as depressed mood, loss of ...

ADC Therapeutics seems to have run headlong into the FDA’s new strict policy on accelerated reviews: Get your confirmatory study in line before filing, or wait. ...

Pharmaceutical company Viatris will acquire the eye disease drug developers Oyster Point Pharma and Famy Life Sciences in separate deals announced Monday.  ...

The FDA has placed a hold on Verve Therapeutics’ Investigational New Drug (IND) application to conduct a clinical trial evaluating the company’s VERVE-101 gene editing treatment to inactivate a...

Study shows combining brentuximab vedotin with the standard chemotherapy regimen reduced the risk of relapse in children with high-risk Hodgkin lymphoma by 10%. ...

The company’s BCMA-targeted Blenrep has failed a phase 3 trial in relapsed or refractory multiple myeloma. The GSK antibody-drug conjugate didn’t outdo Bristol Myers Squibb’s Pomalyst and low...

AstraZeneca and Sanofi have secured approval in the EU for Beyfortus, the first single-dose drug to protect newborns and infants from respiratory syncytial virus (RSV) infections. ...