UNITED KINGDOM — GSK’s myelofibrosis therapy, Ojjaara, also known as momelotinib, has received the coveted stamp of approval from the US Food and Drug Administration (FDA). This development marks a…
Read MoreTag: US FDA
Biocon Generics Inc. snaps up Eywa Pharma’s oral solid manufacturing site in the United States
INDIA – Biocon Generics Inc., a wholly-owned subsidiary of Biocon, has acquired Eywa Pharma Inc.’s oral solid dosage manufacturing facility in the United States in a deal valued at US$7.7…
Read MoreRoche faces delay in FDA decision for subcutaneous Tecentriq cancer immunotherapy
SWITZERLAND — Roche’s eagerly awaited subcutaneous version of its groundbreaking cancer immunotherapy Tecentriq may not receive its anticipated FDA decision on time. The FDA was set to deliver a verdict…
Read MoreSandoz secures landmark FDA approval for biosimilar of Biogen’s Tysabri
USA — In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has given its nod to Tyruko (natalizumab-sztn), a biosimilar designed as a counterpart to Biogen’s Tysabri (natalizumab)…
Read MoreMedtronic takes swift action in hemodialysis catheter recall to uphold patient safety
USA — In a bid to uphold patient safety, Medtronic’s recent recall of hemodialysis catheters has been classified as a Class I event by the U.S. Food and Drug Administration…
Read MorePfizer’s innovative bispecific treatment receives FDA accelerated approval for multiple myeloma
USA —The Food and Drug Administration (FDA) has granted accelerated approval to Pfizer’s groundbreaking drug, Elrexfio. This momentous decision marks the third of its kind, positioning Elrexfio as a beacon…
Read MoreArcellx overcomes hurdles to revive clinical trial for multiple myeloma cell therapy
USA —Biotechnology frontrunner Arcellx has received the green light from the Food and Drug Administration (FDA) to recommence a pivotal clinical trial involving a pioneering cell therapy for multiple myeloma.…
Read MoreFDA approves GE Healthcare’s wireless patient monitoring system
USA — GE HealthCare, a prominent US healthcare technology company, has secured a significant milestone with the US Food and Drug Administration (FDA) granting 510(k) approval for its groundbreaking Portrait…
Read MoreBoston Scientific’s POLARx Cryoablation System garners FDA approval
USA —US-based medical innovator Boston Scientific has achieved a monumental feat with the US Food and Drug Administration (FDA) granting approval for the POLARx Cryoablation System. This innovative system stands…
Read MoreFDA greenlights Johnson & Johnson’s Akeega for BRCA-positive prostate cancer
USA — Johnson & Johnson has secured the coveted FDA approval for Akeega, a pioneering combination tablet poised to redefine the landscape of metastatic castration-resistant prostate cancer (mCRPC) treatment in…
Read More