Akero’s Efruxifermin Receives the US FDA’s Breakthrough Therapy Designation for Nonalcoholic Steatohepatitis
Shots: The US FDA has granted the BTD to efruxifermin for NASH. The designation wa...
Takeda’s Qdenga Receives EC’s Approval for the Prevention of Dengue Disease in Patients Aged ≥4 Years
Shots: The approval was based on the results from the 19 P-I/II/III trials incl. 4...
Ascletis Receives the US FDA’s IND Approval of ASC11 for the Treatment of COVID-19
Shots: The NMPA has approved the IND application to initiate the P-I trial of ASC1...
Ultromics’ EchoGo Heart Failure as a Breakthrough Device Receives the US FDA’s Clearance for the Detection of Heart Failure with P...
Shots: Ultromics has received the US FDA clearance for EchoGo Heart Failure, an AI...
Ionis Reports EMA Acceptance of MAA for Tofersen to Treat Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis
Shots: The EMA has accepted the MAA of tofersen for review to treat SOD1 ALS. Tofe...
Rigel’s Rezlidhia (olutasidenib) Receives the US FDA’s Approval for the Treatment of Acute Myeloid Leukemia with a Susceptible IDH...
Shots: The US FDA has approved Rezlidhia for patients with r/r AML with a suscepti...
