Merck’s KEYTRUDA QLEX™ Secures FDA Approval as First Subcutaneous Pembrolizumab Injection
Merck & Co., known as MSD outside of the United States and Canada, announced on Saturday that the U.S. Food
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Regulatory
FDA Approves J&J’s Inlexzo™ Breakthrough Bladder Cancer Therapy
Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved INLEXZO™ (gemcitabine intravesical system), a
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Boehringer’s HERNEXEOS® Wins Accelerated FDA Nod in Lung Cancer
In a landmark decision for HER2-mutant lung cancer, the US FDA has granted accelerated approval to Boehringer Ingelheim’s HERNEXEOS® (zongertinib),
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Novartis Gains First-ever Approval for Infant Malaria Medicine
In a breakthrough for pediatric malaria treatment, Novartis has received approval from Swissmedic for Coartem® (artemether-lumefantrine) Baby, marking the first-ever
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FDA Approves Gilead’s Yeztugo® (Lenacapavir) as First Biannual Injectable HIV PrEP
Gilead Sciences, Inc. (Nasdaq: GILD) has announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir) as
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Novartis Secures Landmark FDA Approval for Fabhalta® in Rare Kidney Disease
Novartis has received its third U.S. Food and Drug Administration (FDA) approval for Fabhalta® (iptacopan), marking a major milestone as
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Driving Efficiency and Compliance in Pharma with SenseAnywhere’s Next-Gen Temperature Monitoring Solutions
In today’s strictly regulated pharmaceutical industry, the need for temperature monitoring solutions is paramount. The quality, reliability, and durability of
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Pfizer’s ADCETRIS® Approved by FDA for Relapsed or Refractory Large B-Cell Lymphoma
Pfizer announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS® (brentuximab vedotin) in combination with
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EC Greenlights ViiV Healthcare and J&J’s HIV-1 Combo for Adolescents
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced today that
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Complying with Mandates for Manufacture of Sterile Products
Maintaining traceability in pharmaceutical manufacturing processes is of utmost importance in navigating the intricate landscape of government regulations that influence
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