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646 News Found

Bayer files for approval of finerenone in heart failure in Japan
News | February 15, 2025

Bayer files for approval of finerenone in heart failure in Japan

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


Strides Pharma debuts with ESG rating of 76/100 in the S&P Global’s CSA 2024
Sustainability | January 23, 2025

Strides Pharma debuts with ESG rating of 76/100 in the S&P Global’s CSA 2024

Scored 85/100, 2.3x the industry average in Social and 73/100, 1.8x the industry average in Governance


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations


USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs
Policy | January 16, 2025

USFDA will no longer allow for use of FD&C Red No. 3 in food and ingested drugs

The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies
Clinical Trials | January 10, 2025

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients


Nano-formulation of darkness hormone could be therapeutic solution for Parkinson's disease
News | January 04, 2025

Nano-formulation of darkness hormone could be therapeutic solution for Parkinson's disease

Parkinson's disease (PD) is one of the most common neurological disorders caused by the death of dopamine-secreting neurons in the brain