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Results For "ANDA"

3105 News Found

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer
Drug Approval | February 27, 2026

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer

BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results


Novo Nordisk & Vivtex team up to revolutionize oral hiologics
News | February 27, 2026

Novo Nordisk & Vivtex team up to revolutionize oral hiologics

Under the deal, Vivtex will license select oral drug-delivery technologies to Novo Nordisk


Zydus to disrupt GLP-1 market with day-1 launch of innovative Semaglutide in India
News | February 26, 2026

Zydus to disrupt GLP-1 market with day-1 launch of innovative Semaglutide in India

Zydus has developed an innovative Semaglutide Injection (15 mg/3 ml) in a prefilled cartridge administered using a patient-friendly reusable pen for which the company has exclusive rights


Genprex bags major patent wins in Japan & Europe for REQORSA cancer therapy
R&D | February 26, 2026

Genprex bags major patent wins in Japan & Europe for REQORSA cancer therapy

The Japanese Patent Office has issued a favorable Appeal Decision granting a patent for the use of REQORSA Gene Therapy in combination with PD-L1 antibodies to treat cancer


Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets
Drug Approval | February 26, 2026

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder


Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%
Drug Approval | February 25, 2026

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.


Caplin Steriles gets USFDA approval for Sodium Phosphate injection
Drug Approval | February 25, 2026

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake


Starton Therapeutics doses first patient in Phase 2a trial of STAR-LLD for multiple myeloma
Biotech | February 25, 2026

Starton Therapeutics doses first patient in Phase 2a trial of STAR-LLD for multiple myeloma

The Phase 2 trial, conducted through Starton’s Sargon Site Network, is expanding from two to six sites across the U.S.