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5052 News Found

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


Evofem's SOLOSEC submitted for regulatory approval in the UAE
News | October 06, 2025

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


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


Rona submits IND for GalNAc-conjugated siRNA targeting obesity
Drug Approval | September 16, 2025

Rona submits IND for GalNAc-conjugated siRNA targeting obesity

RN3161 is engineered to reduce fat while preserving lean mass, setting it apart from current treatment options


AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
Drug Approval | August 06, 2025

AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial


Johnson & Johnson submits additional data to FDA on psoriatic arthritis
News | August 03, 2025

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study


GlaxoSmithKline Pharmaceuticals reports Q1 FY26 PAT at Rs. 205 Cr
News | August 03, 2025

GlaxoSmithKline Pharmaceuticals reports Q1 FY26 PAT at Rs. 205 Cr

The performance was below anticipated levels, primarily due to external factors such as seasonal disruption that affected overall results