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News about "US FDA Approval"
US FDA Approves KEYTRUDA-WELIREG Combination for Adjuvant ccRCC
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for the adjuvant treatment of certain patients with clear cell Renal Cell Carcinoma (ccRCC). The approval expands treatment options for kidney cancer patients at high risk of recurrence following surgery.
US FDA Approval | 15/06/2026 | By News Bureau
US FDA Approves Bayer's AMBELVIST for Contrast-Enhanced MRI
Bayer’s AMBELVIST (gadoquatrane) has received US FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the Central Nervous System (CNS) and other body regions. The approval expands advanced imaging options with a next-generation gadolinium-based contrast agent for improved diagnostic evaluation.
US FDA Approval | 15/06/2026 | By News Bureau
US Approves TRUQAP for PTEN-Deficient Metastatic Prostate Cancer
TRUQAP (capivasertib) has been approved in the US as the first targeted treatment for PTEN-deficient metastatic Hormone-Sensitive Prostate Cancer (mHSPC). The approval is supported by phase 3 CAPItello-281 data showing a 19 percent reduction in the risk of disease progression or death.
US FDA Approval | 15/06/2026 | By News Bureau
Alembic Pharmaceuticals Announces US FDA Final Approval for Tretinoin Cream
Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) final approval for Tretinoin Cream USP, 0.05 percent, a generic version of Bausch Health’s Retin-A Cream.
US FDA Approval | 12/06/2026 | By News Bureau
US FDA Approves Pfizer's HYMPAVZI for Treatment of Additional Hemophilia A and B Patients
Pfizer’s HYMPAVZI has received expanded US FDA approval for hemophilia A and B patients aged 12 years and older with inhibitors, as well as children aged 6-11 years with or without inhibitors. The approval makes HYMPAVZI the first subcutaneous non-factor therapy available for pediatric hemophilia B patients ages 6 to 11 years old.
US FDA Approval | 09/06/2026 | By News Bureau
Lupin Receives US FDA Approval for Interchangeable Biosimilar Ranibizumab, Ranluspec
Lupin has secured US FDA approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis, expanding its biosimilars portfolio and broadening access to treatments for retinal and vision-related disorders.
US FDA Approval | 05/06/2026 | By News Bureau
Alembic Pharma Receives USFDA Approval for Haloperidol Tablets
Alembic Pharmaceuticals has received final US FDA approval for Haloperidol Tablets USP in multiple strengths. The medication is indicated for the management of psychotic disorders and the treatment of tics and vocal utterances associated with Tourette’s Disorder in both children and adults, expanding Alembic’s US CNS product portfolio.
US FDA Approval | 05/06/2026 | By News Bureau
US FDA Releases Draft Guidance to Accelerate Cell and Gene Therapy Development
The US FDA has issued draft guidance aimed at accelerating the development of cell and gene therapies by enabling sponsors to leverage existing scientific evidence, reduce redundant testing for treatments targeting rare and life-threatening diseases.
US FDA Approval | 04/06/2026 | By News Bureau
Lupin and Natco Secure USFDA Approval for Generic Cancer Drug Eribulin Mesylate Injection
Lupin and Natco Pharma have received USFDA approval for Eribulin Mesylate Injection, a generic equivalent of Halaven, used in the treatment of advanced breast cancer and liposarcoma.
US FDA Approval | 03/06/2026 | By News Bureau
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.
US FDA Approval | 02/06/2026 | By News Bureau
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