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FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
Drug Approval | November 21, 2025

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options


Ingenus Pharma launches first FDA-approved generic version of Premarin
Drug Approval | November 18, 2025

Ingenus Pharma launches first FDA-approved generic version of Premarin

Conjugated Estrogens Tablets are indicated for moderate to severe menopausal symptoms, including hot flashes, and for the prevention of postmenopausal osteoporosis in women at significant risk


Zydus receives final approval from USFDA for Leuprolide Acetate injection
Drug Approval | November 15, 2025

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer


Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg
Drug Approval | November 14, 2025

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis


Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor


FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer
Drug Approval | November 14, 2025

FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue


Moraine appointed as distributor for OTSAW’s Hospital robots in Japan
Medical Device | November 12, 2025

Moraine appointed as distributor for OTSAW’s Hospital robots in Japan

Moraine will serve as OTSAW’s exclusive distributor in Japan, deploying the Camello+ autonomous mobile robot and TransCar autonomous guided vehicle to support hospital logistics