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Results For "New-Drug-Application"

456 News Found

Lupin launches generic Brivaracetam oral solution in US to treat epilepsy
News | February 25, 2026

Lupin launches generic Brivaracetam oral solution in US to treat epilepsy

Brivaracetam is the bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB


FDA accepts Teva’s NDA for long-acting schizophrenia injection
Drug Approval | February 21, 2026

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations


Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria
Clinical Trials | February 20, 2026

Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria

The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options


FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma
Drug Approval | February 18, 2026

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent


Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough
Drug Approval | February 16, 2026

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US


Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
Drug Approval | February 07, 2026

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets


Lupin launches Topiramate ER capsules in US
News | February 05, 2026

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals


Indoco Remedies bags USFDA nod for Lacosamide oral solution
News | February 02, 2026

Indoco Remedies bags USFDA nod for Lacosamide oral solution

The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa