Tag: BTD

Fifth BTD for AbbVie and Genentech Drug

AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in c...

Amicus Got BTD for Late Onset Pompe Disease Treatment

Amicus Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted to Amicus a Breakthrough Therapy Designation (“BTD”) to AT-GAA for the treatment of late onset Pompe disease,...

BTD for FInch’s C. Difficile Drug

Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium dif...

BTD for AstraZeneca’s LRTI Drug

AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respir...

Roche Plans to Expand Use of its Breast Cancer Drug

Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla (trastuzumab emtansine) to include the adjuvant treatment of people with HER2-positive e...