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Results For "New-Drug-Application"

350 News Found

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer
Diagnostic Center | June 02, 2025

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer


Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP
Drug Approval | May 24, 2025

Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP

Allopurinol is used to prevent or lower high uric acid levels in the blood


Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin


Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection
Drug Approval | May 14, 2025

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy


Lupin launches Eslicarbazepine Acetate tablets in US
Drug Approval | May 08, 2025

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity


Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
News | May 06, 2025

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

Topiramate is indicated as a treatment of epilepsy and migraine


Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg
Drug Approval | May 03, 2025

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,


Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | May 01, 2025

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension