FDA grants RMAT designation to SanBio’s cell therapy
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation...
Read More...
Focus:
North-america
-
![]()
Novartis presents additional Zolgensma data in children with SMA
Novartis subsidiary AveXis has announced interim data for Zolgensma (onasemnogene abeparvovec-xioi) in children with spinal...
Read More...
-
![]()
Pfizer’s Upjohn and Mylan merger set to create drug and manufacturing juggernaut
This partnership will combine pipeline and marketed product portfolios, filling therapy area gaps as well...
Read More...
-
![Roche receives FDA breakthrough status for lupus nephritis drug Gazyva]()
Roche receives FDA breakthrough status for lupus nephritis drug
Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for...
Read More...
-
![Keytruda combination endometrial carcinoma]()
FDA approves Keytruda plus Lenvima for endometrial carcinoma
The US Food and Drug Administration (FDA) has approved Merck’s anti-programmed cell death protein 1...
Read More...
-
![US FDA partners Australia and Canada for cancer therapies review]()
US FDA partners Australia and Canada for cancer therapies review
The US Food and Drug Administration (FDA) has partnered with the Australian Therapeutic Goods Administration...
Read More...
-
Oncoheroes signs cancer asset licensing deal with Boehringer
US-based biotech company Oncoheroes Biosciences has entered into a licensing agreement with Boehringer Ingelheim for...
Read More...
-
![Ebola vaccine Merck]()
FDA grants Merck’s V920 Ebola vaccine priority review
Merck has announced that the US Food and Drug Administration (FDA) has accepted a biologics...
Read More...
-
![]()
Smoke and mirrors: The complicated truth about vaping
There are at least 215 possible cases across 25 states where the development of severe...
Read More...
-
![FDA fast tracks review of AstraZeneca’s Farxiga in heart failure]()
FDA fast tracks review of AstraZeneca’s Farxiga in heart failure
The US Food and Drug Administration (FDA) has awarded fast track designation for the review...
Read More...
