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News about "FDA Approval"
US FDA Approves Ziihera for First-Line HER2+ Gastroesophageal Cancer
The US Food and Drug Administration (FDA) approves Ziihera plus tislelizumab and chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma regardless of PD-L1 status.
FDA Approval | 26/08/2026 | By News Bureau
Otsuka Receives US FDA Approval for First-in-Class SIMTRIYO
The US Food and Drug Administration (FDA) has approved Otsuka's SIMTRIYO, the first Norepinephrine, Dopamine, Serotonin Reuptake Inhibitor (NDSRI) for treating ADHD in adults and children aged 6 years and older weighing at least 20 kg.
FDA Approval | 27/07/2026 | By News Bureau
US FDA Approves TYLENOL with Naproxen for OTC Use
The US Food and Drug Administration (FDA) has approved TYLENOL with Naproxen, the first OTC fixed-dose acetaminophen and naproxen combination offering up to 12 hours of pain relief.
FDA Approval | 25/07/2026 | By News Bureau | 168
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 | 113
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 | 137
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
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 | 180
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 | 106
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 | 126
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