Pharma News

Santhera Pharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational drug vamorolone for treatment of patients with Duc...

Otsuka subsidiary Taiho Oncology has gained an accelerated approval from the FDA for its Lytgobi (futibatinib) tablets for treatment of adult patients with previously treated, unresectable, locally...

Biotech company Zealand Pharma A/S, an innovator in peptide-based medicines, announced the positive topline results from its phase 3 trial of glepaglutide on Friday. ...

The UK’s National Institute for Health and Care Excellence (NICE) said it does not recommend PTC Therapeutics’ gene therapy Translarna (ataluren) for routine funding in the National Health Ser...

An enzyme called Fic, whose biochemical role was discovered at UT Southwestern more than a dozen years ago, appears to play a crucial part in guiding the cellular response to stress, a new study su...

Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the U.S. Food and...

The biopharma world – and markets – spent Thursday evening reacting as the FDA gave the green light to only its third-ever drug for ALS, Amylyx‘s AMX0035.  ...

Celltrion’s Vegzelma (bevacizumab-adcd) has received FDA’s approval for treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous nonsmall-cell lung cancer (nsNSCLC); recu...

Shionogi said that its investigational COVID-19 treatment ensitrelvir fumaric acid has shown promising results in a phase 3 clinical trial.

CRISPR Therapeutics has received a Regenerative Medicine Advanced Therapy designation from the FDA for its CTX130 for treatment of patients with either of two types of cutaneous T-cell lymphoma —...

Enalare Therapeutics has secured a contract from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $50.3 million for its investigational respiratory stimulant ENA-001. ...

The FDA has granted a Priority Review to Pharming’s New Drug Application (NDA) for leniolisib to treat patients with activated phosphoinositide 3-kinase delta syndrome (APDS) who are 12 years an...