BMS and bluebird Bio's competing BCMA cell therapy Abecma (idecabtagene vicleucel or ide-cel) was approved by the FDA in March, and was also filed for approval with the EMA, initially with ...

It’s also important to read the Abecma label and other paperwork that may come with the drug. If you need help reading or understanding this information, ask your doctor or pharmacist.

and a decision on the label extension application of IXCHIQ ® in the European Union (EU), Norway, Liechtenstein and Iceland is expected within sixty days. Juan Carlos Jaramillo, M.D., Chief ...

The European Medicines Agency (EMA) has issued a warning about the dangers of unregulated advanced therapy medicinal products (ATMPs) being illegally offered to patients in Europe. ATMPs encompass ...

of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva’s single-dose vaccine for the prevention of disease caused ...

2seventy bio, a Cambridge-based biotech formerly part of bluebird bio, helped develop the first FDA-approved CAR T cell therapy for multiple myeloma, Abecma. Abecma was once considered a $1bn per ...

ANI Pharmaceuticals (ANIP) announced that the U.S. FDA has approved an expanded label for Iluvien that includes an indication for the treatment of chronic non-infectious uveitis affecting the ...

The deal caps a turbulent three years for 2seventy bio. The company served as the oncology business of Bluebird Bio until Bluebird spun out 2seventy in 2021.

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq; 15 mg, once ...

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union ... for Medicinal Products for Human Use (CHMP) of the European Medicines ...