US FDA approves Syndax's blood cancer drug
The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and ...
In RFK Jr., drugmakers face an antagonist with regulatory power
Anxious and bewildered, some drugmakers are reaching out to their lobbyists about how Robert Kennedy’s pending nomination ...
FDA grants orphan drug designation to potential treatment of STXBP1 developmental and epileptic encephalopathy
Research that was carried out by Baylor College of Medicine and Texas Children's Hospital doctors has led to the U.S. Food ...
FiercePharma2d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Monthly Prescribing Reference11d
FDA Drug Approval Decisions Expected in December 2024
If approved, sotagliflozin would be the first oral medication for patients with T1D. The FDA is reviewing the BLA for datopotamab deruxtecan (Dato-DXd), a specifically engineered TROP2-directed DXd ...
MassDevice11d
NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...
DC Judge Upholds FDA Drug Approval in Big Pharma Dispute
"The FDA's approval of Lumryz was not arbitrary or capricious," U.S. District Judge Amit P. Mehta wrote in a memorandum ...
MassDevice16d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
Pharmabiz16d
US FDA grants accelerated approval to Novartis’ Scemblix for adult patients with newly diagnosed Ph+ CML-CP
US FDA grants accelerated approval to Novartis’ Scemblix for adult patients with newly diagnosed Ph+ CML-CP: East Hanover Thursday, October 31, 2024, 12:00 Hrs [IST] Novartis an ...
GlobalData on MSN17d
Novartis’ Scemblix gains FDA approval for leukaemia
Novartis has received US Food and Drug Administration (FDA) accelerated approval for Scemblix (asciminib) to treat adults ...
pharmaphorum17d
Novartis gets FDA okay for frontline use of Scemblix in CML
The new accelerated approval covers the use of Scemblix for newly diagnosed patients with Philadelphia chromosome-positive ...