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2187 News Found

Senores Pharmaceuticals receives Philippine FDA approval for 10 products
Drug Approval | December 05, 2025

Senores Pharmaceuticals receives Philippine FDA approval for 10 products

Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region


FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Drug Approval | December 04, 2025

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor


FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension
Drug Approval | December 04, 2025

FDA nod to priority review to AstraZeneca’s Baxdrostat for hard-to-control hypertension

Here's a development that aims to keep your blood pressure in check. Literally!


Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease
Clinical Trials | December 03, 2025

Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease

Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss


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


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


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


Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
Drug Approval | November 30, 2025

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026


a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


Novo Nordisk fast-tracks higher-dose obesity drug to FDA
Clinical Trials | November 27, 2025

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway