Drugmakers seek clarity from FDA on manufacturing interruption notifications
Back in April, the FDA published draft guidance on when and how a pharma company can notify the agency of an interruption or halt to
Back in April, the FDA published draft guidance on when and how a pharma company can notify the agency of an interruption or halt to
Merck’s Keytruda notched another positive set of data, this time in a rare cancer of the esophagus that sets up the company to receive full
Biotechs left and right announced stock sales this week after data drops at ASCO, the European Hematology Association’s annual meeting and elsewhere. The famed genome
Coherus BioSciences is making a small stock-for-stock transaction to shore up its immuno-oncology pipeline in an acquisition of Surface Oncology that is valued at $65
Twist Bioscience is laying off 212 employees, effective July 3, according to California WARN notices — with 197 of those staffers in San Francisco. The
→ Preston Klassen has mapped out his next destination as president and R&D chief of microRNA developer Regulus Therapeutics. Klassen was the CEO of Metacrine,
The FDA granted accelerated approval to Genentech’s CD20xCD3 bispecific for patients with a certain type of non-Hodgkin’s lymphoma on Thursday night, as the Roche unit
GSK’s blood cancer drug momelotinib has taken another turn on its winding journey, with the FDA delaying its review of the investigational tablet that GSK
Use of video rather than direct laryngoscope led to better rates of successful tracheal intubation on the first attempt for critically ill patients in the
High-dose hemodiafiltration improved survival compared with standard hemodialysis for patients with kidney failure resulting in the need for kidney-replacement therapy, according to the randomized CONVINCE