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Tag: US FDA

GSK’s Ojjaara wins FDA approval for myelofibrosis patients battling anaemia

18 September 202318 September 2023

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…

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Biocon Generics Inc. snaps up Eywa Pharma’s oral solid manufacturing site in the United States

13 September 202313 September 2023

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…

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Roche faces delay in FDA decision for subcutaneous Tecentriq cancer immunotherapy

11 September 202311 September 2023

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…

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Sandoz secures landmark FDA approval for biosimilar of Biogen’s Tysabri

25 August 202325 August 2023

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)…

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Medtronic takes swift action in hemodialysis catheter recall to uphold patient safety

18 August 202320 August 2023

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…

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Pfizer’s innovative bispecific treatment receives FDA accelerated approval for multiple myeloma

16 August 202316 August 2023

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…

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Arcellx overcomes hurdles to revive clinical trial for multiple myeloma cell therapy

16 August 202316 August 2023

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.…

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FDA approves GE Healthcare’s wireless patient monitoring system

15 August 202315 August 2023

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…

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Boston Scientific’s POLARx Cryoablation System garners FDA approval

15 August 202315 August 2023

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…

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FDA greenlights Johnson & Johnson’s Akeega for BRCA-positive prostate cancer

14 August 202314 August 2023

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…

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