News about "USFDA approval"

Alembic Pharma Receives US FDA Approval for Generic Tretinoin Cream

Alembic Pharmaceuticals has secured final USFDA approval for its generic Tretinoin Cream USP, 0.05 percent, used in the treatment of acne vulgaris, targeting a US market estimated at USD 76 million.

USFDA Approval | 16/06/2026 | By News Bureau |  106

Tempus Wins FDA Approval for xT CDx, Expanding Solid Tumor Testing Portfolio

Tempus has received US FDA approval for its tumor-only xT CDx, becoming the first laboratory with companion diagnostic approval for both tumor-only and tumor-normal genomic profiling.

USFDA Approval | 30/05/2026 | By News Bureau |  157

US FDA Approves DECNUPAZ for Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

AbbVie has received US FDA approval for DECNUPAZ to treat adults with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), marking the first and only outpatient-initiated ADC for BPDCN and AbbVie’s first approved Antibody Drug Conjugate (ADC) for hematologic malignancies.

USFDA Approval | 30/05/2026 | By News Bureau

US FDA Approves INQOVI Plus Venetoclax for AML

The US Food and Drug Administration (FDA) approves INQOVI with venetoclax as the first all-oral combination treatment for acute myeloid leukemia patients ineligible for intensive chemotherapy, supported by positive ASCERTAIN-V trial data.

USFDA Approval | 14/05/2026 | By News Bureau |  120

Lupin Secures FDA Approval for Famotidine Injection USP

Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials.

USFDA Approval | 14/05/2026 | By News Bureau |  146

Partner Therapeutics Wins FDA Approval for BIZENGRI in NRG1+ Cholangiocarcinoma

Partner Therapeutics receives US Food and Drug Administration (FDA) approval for BIZENGRI, the first targeted therapy for NRG1 fusion-positive cholangiocarcinoma, expanding use across NSCLC and pancreatic cancer.

USFDA Approval | 12/05/2026 | By News Bureau

Accord Healthcare US Relaunches Tadalafil Tablets with Expanded Dosage Availability

Accord Healthcare US relaunches Tadalafil tablets with expanded dosage strengths to improve access for treating Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia (BPH), including ED/BPH combination therapy.

USFDA Approval | 05/05/2026 | By News Bureau

Lupin Receives US FDA Approval for Glycerol Phenylbutyrate Oral Liquid

Lupin secures US Food and Drug Administration (FDA) approval for Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL), bioequivalent to Ravicti Oral Liquid.

USFDA Approval | 05/05/2026 | By News Bureau

Incyte Wins US FDA Approval for Jakafi XR (Ruxolitinib)

The US Food and Drug Administration (FDA) approves Incyte Corporation’s Jakafi XR (ruxolitinib), a once-daily extended-release tablet for myelofibrosis, polycythemia vera and GVHD, offering consistent day-long exposure.

USFDA Approval | 02/05/2026 | By News Bureau |  199

US FDA Approves CAPLYTA (lumateperone) sNDA for Schizophrenia Relapse Reduction

US Food and Drug Administration (FDA) approves CAPLYTA (lumateperone) sNDA for schizophrenia, showing a 63 percent reduction in relapse risk and 84 percent relapse-free patients over six months, with strong long-term safety and stability data.

USFDA Approval | 28/04/2026 | By News Bureau |  131