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3713 News Found

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease
Drug Approval | September 29, 2025

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option


Alkem launches pertuzumab biosimilar ‘Pertuza’ for treatment of HER2-positive breast cancer
News | September 24, 2025

Alkem launches pertuzumab biosimilar ‘Pertuza’ for treatment of HER2-positive breast cancer

Alkem's Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab


AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment
Clinical Trials | September 18, 2025

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo


Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet
News | September 16, 2025

Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet

EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke


Aptar Pharma partners with Dianosic to advance ARIS platform for treatment of chronic allergic rhinitis and rhinosinusitis
News | September 08, 2025

Aptar Pharma partners with Dianosic to advance ARIS platform for treatment of chronic allergic rhinitis and rhinosinusitis

Agreement further expands Aptar Pharma’s leading position in nasal delivery solutions and addresses significant unmet needs of delivering drugs locally over extended periods


FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease
Drug Approval | September 02, 2025

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease


FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
Drug Approval | August 25, 2025

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB