News about "FDA Approval"

US FDA Approves Accord BioPharma's ENNUMO Pegfilgrastim Biosimilar

The US Food and Drug Administration (FDA) has approved Accord BioPharma’s ENNUMO (pegfilgrastim-pccg), expanding its US biosimilar portfolio and strengthening access to G-CSF therapies for cancer patients.

FDA Approval | 10/07/2026 | By News Bureau

Hikma Welcomes FDA Approval of Guardant360 Liquid CDx, Expanding Precision Cancer Diagnostics

The FDA-approved Guardant360 Liquid CDx enables advanced cancer biomarker testing through a simple blood draw, supporting faster and more precise treatment decisions.

FDA Approval | 25/06/2026 | By News Bureau

Allergan Aesthetics Secures FDA Approval for Skinvive by Juvederm to Treat Neck Wrinkles

Allergan Aesthetics, an AbbVie company, has received US FDA approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance.

FDA Approval | 18/06/2026 | By News Bureau

Bayer Secures US FDA Approval for Ambelvist, a Low-Dose MRI Contrast Agent

Bayer’s Ambelvist (gadoquatrane) has received US FDA approval for contrast-enhanced MRI in adults and children, offering effective lesion visualization while reducing gadolinium exposure through a low-dose formulation.

FDA Approval | 16/06/2026 | By News Bureau

FDA Expands Approval of Agilent's PD-L1 Diagnostic Test on Dako Omnis Platform for Four Additional Cancer Types

Agilent Technologies has received FDA approval to expand the use of its PD-L1 IHC 22C3 pharmDx test on the Dako Omnis platform, broadening access to PD-L1 testing for four additional tumour types and supporting streamlined pathology laboratory operations.

FDA Approval | 05/06/2026 | By News Bureau |  144

Lupin Receives US FDA Approval for Sodium Sulfate, Magnesium Sulfate and Potassium Chloride Tablets

Lupin has received US FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, a bioequivalent to Reference Listed Drug (RLD) Sutab Tablets of Azurity Pharmaceuticals.

FDA Approval | 02/06/2026 | By News Bureau

FDA Grants Accelerated Approval to BeOne Medicines' Beqalzi for Relapsed Mantle Cell Lymphoma

BeOne Medicines has secured accelerated US FDA approval for Beqalzi (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma, marking an advancement in targeted therapies for patients with limited treatment options.

FDA Approval | 16/05/2026 | By News Bureau |  105

Axsome Therapeutics Secures US Food and Drug Administration Approval for Auvelity in Alzheimer's Agitation

First-in-class therapy approved to treat agitation linked to Alzheimer’s disease, addressing a major unmet need for patients and caregivers.

FDA Approval | 04/05/2026 | By News Bureau

FDA Approves Vanda Pharmaceuticals' BYSANTI as First-Line Therapy for Bipolar I Disorder and Schizophrenia

BYSANTI (milsaperidone), a new atypical antipsychotic from Vanda Pharmaceuticals, gains FDA approval for acute manic or mixed episodes in bipolar I disorder and schizophrenia in adults, with US launch planned for Q3 2026.

FDA Approval | 21/02/2026 | By News Bureau |  309

Novartis' Remibrutinib Shows Positive Phase III Results in Chronic Inducible Urticaria

Pivotal RemIND trial meets primary endpoint across three major CIndU subtypes, positioning oral remibrutinib as a potential first targeted therapy for inducible chronic hives.

FDA Approval | 19/02/2026 | By News Bureau |  390