News about "US FDA Approval"

Granules India Secures Sole First-to-File ANDA Status for Sodium Oxybate Extended-Release for Oral Suspension

Granules India secures Sole First-to-File ANDA status for Sodium Oxybate Extended-Release for Oral Suspension, strengthening its US complex generics portfolio.

US FDA Approval | 06/07/2026 | By Akanki

La Chandra Pharmalab Secures US FDA Clearance for Gujarat Hormone API Facility

La Chandra Pharmalab has received a US FDA Establishment Inspection Report (EIR) for its Banaskantha hormone API manufacturing facility, reinforcing its position in regulated markets and advancing India's capabilities in hormone API manufacturing.

US FDA Approval | 03/07/2026 | By News Bureau

Alembic Pharmaceuticals Receives US FDA Approval for Dapsone Gel 5 Percent

Alembic Pharmaceuticals has received US FDA approval for Dapsone Gel 5 percent, a topical treatment for acne vulgaris.

US FDA Approval | 29/06/2026 | By News Bureau

Lupin Receives US FDA Tentative Approval for Enzalutamide Tablets

Lupin has received tentative US Food and Drug Administration (FDA) approval for Enzalutamide tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths.

US FDA Approval | 29/06/2026 | By News Bureau

US FDA Approves Pfizer's Ibrance for Maintenance Treatment of HR+, HER2+ Metastatic Breast Cancer

FDA approval makes Ibrance the first CDK4/6 inhibitor indicated for HR+ metastatic breast cancer regardless of HER2 status.

US FDA Approval | 26/06/2026 | By News Bureau |  242

US FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each with Trodelvy

The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with Trodelvy as first-line treatment for adults with PD-L1-positive (CPS ≥10) advanced Triple-Negative Breast Cancer (TNBC).

US FDA Approval | 26/06/2026 | By News Bureau |  177

US FDA Approves Utebzi for Adult Patients with Complicated UTIs

The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.

US FDA Approval | 19/06/2026 | By News Bureau

Allergan Aesthetics Secures US FDA Approval for Skinvive to Treat Neck Wrinkles

Allergan Aesthetics has received the US Food and Drug Administration (FDA) approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance. The injectable treatment helps the skin retain moisture, softness and smoothness, providing a first-of-its-kind option for addressing age-related and ‘tech-neck’ lines.

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

Lupin Launches Azilsartan Medoxomil Tablets in US

Lupin has launched Azilsartan Medoxomil Tablets in the US, a bioequivalent generic version of Edarbi, indicated for the treatment of hypertension in adults.

US FDA Approval | 17/06/2026 | By News Bureau

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