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Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval
News | December 03, 2025

Cleveland Diagnostics’ IsoPSA test for prostate cancer detection gains FDA approval

Now a test that offers new precision in prostate cancer detection


Lupin receives FDA approval for biosimilar Armlupeg
Biotech | December 01, 2025

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs


SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine
Drug Approval | November 27, 2025

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements


Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets
Drug Approval | November 24, 2025

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea


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


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