Pharma News

The FDA has expanded its approval for AbbVie’s blockbuster antipsychotic drug Vraylar (cariprazine), this time as an adjunctive treatment along with antidepressants to treat adults with major dep...

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their wellbeing safeguarded. ...

The FDA has approved a new indication for pafolacianine (Cytalux) to aid surgeons in detecting lung cancer lesions in adult patients with known or suspected lung cancer. ...

The FDA has approved Ferring’s gene therapy Adstiladrin to treat adults with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer — the first gene therapy approv...

Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder...

Neurophth Therapeutics, Inc. today announced receiving the U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application on the in-vivo gene replacement therap...

The FDA has granted Orphan Drug status to Kintara Therapeutics’ VAL-083 candidate for the treatment of diffuse intrinsic pontine glioma, a rare, very aggressive and hard to treat childhood brain...

Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validatio...

A decision is anticipated in early January about which of the now eight Humira biosimilars will be included.

For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). 

The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). 

The United States Pharmacopeia (USP) and Phlow have teamed up to develop a new lab that will certify and validate pharmaceutical continuous manufacturing processes to facilitate the supply of U.S.-...