Pharma News

The FDA has granted Priority Review to Daiichi Sankyo’s New Drug Application (NDA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine con...

Sumitomo subsidiary Sumitovant has entered into a purchase agreement to acquire all Myovant’s outstanding shares — gaining one promising cancer drug and another for treatment of premenopausal c...

AstraZeneca’s long-troubled cancer immunotherapy tremelimumab has finally secured its first FDA approval, but the regulatory blessing comes in what could be an increasingly competitive tumor typ...

Education and support are critical to getting — and keeping — patients on appropriate therapy. But many oncology patients have gaps in their knowledge of their condition, treatment and existing...

The FDA has approved GSK’s Menveo single vial vaccine for individuals 10 to 55 years old to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W. ...

Eureka Therapeutics has received an Orphan Drug designation for its investigational therapy ET140203 for the treatment of hepatoblastoma, a rare liver tumor that usually occurs in children under f...

Ventatorx Pharmaceuticals’ investigational antibiotic cefepime-taniborbactam has shown promise in a late-stage study for treatment of complicated urinary tract infections. ...

Novavax has received FDA Emergency Use Authorization (EUA) for its adjuvanted COVID-19 vaccine for use as a first booster dose at least six months after completion of primary vaccination with an au...

The FDA has granted Tvardi Therapeutics’s TTI-101 a Fast Track designation for treatment of patients with relapsed/refractory locally advanced, unresectable or metastatic hepatocellular carcinoma...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Avrobio an “innovation passport” under a new accelerated approval pathway — the Innovative Licensing and Acce...

Salarius Pharmaceuticals has paused new patient enrollment in its phase 1/2 clinical trial of seclidemstat for treating people with various forms of sarcoma, after the death of one patient in the ...

After a successful phase 1 study in which PTC518 reduced huntingtin protein by 30% to 50%, the company is pausing the US enrollment of its phase 2 study until additional data is provided to the FDA...