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News about "FDA Approval"
Fapon Biopharma Receives FDA Approval of IND for FP008 for Solid Tumors
FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients.
FDA Approval | 03/03/2025 | By Aishwarya
Nexus Pharmaceuticals Secures FDA Approval for Tacrolimus Injection
Tacrolimus Injection 5 mg/mL (Single-Dose Vial) in a 10-pack will be launching soon.
FDA Approval | 15/02/2025 | By Aishwarya
American Injectables Secures FDA Approval
American Injectables, specialising in sterile injectables, has announced that it has received FDA approval.
FDA Approval | 10/01/2025 | By Abha
Alembic Pharma Secures FDA Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan).
FDA Approval | 21/10/2024 | By Aishwarya | 208
Alembic Pharma Gets FDA Approval for Lamotrigine Extended-Release Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).
FDA Approval | 07/10/2024 | By Aishwarya | 120
Lupin Gets FDA Approval for Bumetanide Injection
Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
FDA Approval | 20/09/2024 | By Aishwarya | 138
Lilly Gets FDA Approval for EBGLYSS for Atopic Dermatitis
Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) approved EBGLYSS (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis.
FDA Approval | 17/09/2024 | By Aishwarya | 145
FDA Approves Amgen's IMDELLTRA for Advanced Small Cell Lung Cancer
The approval is based on the encouraging response rate and duration of response (DoR) observed in clinical studies, under the FDA's accelerated approval pathway.
FDA Approval | 17/05/2024 | By Abha | 112
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