News about "USFDA approval"

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 |  101

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

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 |  140

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

Cellenkos Inc. Wins US FDA Clearance for Phase 2 Trial of CK0801 in Aplastic Anemia

Cellenkos Inc. receives US Food and Drug Administration (FDA) clearance to initiate a Phase 2 multicentre trial of CK0801, evaluating safety and efficacy of cord blood-derived Tregs in transfusion-dependent aplastic anemia patients.

USFDA Approval | 27/04/2026 | By News Bureau

US FDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing Loss

US Food and Drug Administration (FDA) approves Regeneron’s Otarmeni, the first AAV-based gene therapy, offering a potential treatment for severe-to-profound hearing loss.

USFDA Approval | 27/04/2026 | By News Bureau |  107

US FDA Approves Sanofi's Tzield to Delay Type 1 Diabetes Progression in Children

Sanofi’s Tzield gains US FDA approval to delay stage-III Type 1 Diabetes in children aged one year and above, the first disease-modifying therapy for stage-II T1D.

USFDA Approval | 24/04/2026 | By News Bureau