Category Regulatory

Pill Penalty

New Study Exposes Harmful Effects of IRA’s ‘Pill Penalty’ on Small Molecule Drugs

New Study Exposes Harmful Effects of IRA’s ‘Pill Penalty’ on Small Molecule Drugs A recently published peer-reviewed study is shedding light on the unintended yet far-reaching consequences of the Inflation Reduction Act (IRA) on the U.S. biopharmaceutical sector—particularly in the…

Read MoreNew Study Exposes Harmful Effects of IRA’s ‘Pill Penalty’ on Small Molecule Drugs
VYVGART

FDA Approves VYVGART Hytrulo Prefilled Syringe with ENHANZE for Self-Injection in gMG and CIDP

FDA Approves VYVGART Hytrulo Prefilled Syringe with ENHANZE for Self-Injection in gMG and CIDP In a major development for patients suffering from chronic neuromuscular autoimmune disorders, Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted…

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Cancer

New Cancer Cell Study Backs CEL-SCI’s Early Approval Bid for Multikine in Head & Neck Cancer

New Cancer Cell Study Backs CEL-SCI’s Early Approval Bid for Multikine in Head & Neck Cancer CEL-SCI Corporation (NYSE American: CVM), a clinical-stage immunotherapy company developing innovative treatments for cancer and infectious diseases, today announced findings that reinforce the scientific…

Read MoreNew Cancer Cell Study Backs CEL-SCI’s Early Approval Bid for Multikine in Head & Neck Cancer
Opdivo

FDA Approves Opdivo Plus Yervoy® for Untreated MSI-H or dMMR Metastatic Colorectal Cancer

FDA Approves Opdivo Plus Yervoy® for Untreated MSI-H or dMMR Metastatic Colorectal Cancer Bristol Myers Squibb today announced a major milestone in cancer immunotherapy with the U.S. Food and Drug Administration (FDA) granting approval for the combination of Opdivo® (nivolumab)…

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Sentynl

Sentynl Unveils First Full Clinical Data Supporting NULIBRY® for MoCD Type A

Sentynl Unveils First Full Clinical Data Supporting NULIBRY® for MoCD Type A Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company and a wholly owned subsidiary of Zydus Lifesciences Ltd. (“Zydus Group”), has proudly announced the publication of pivotal clinical studies…

Read MoreSentynl Unveils First Full Clinical Data Supporting NULIBRY® for MoCD Type A