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1569 News Found

Moderna announces updates on pandemic influenza program
News | January 21, 2025

Moderna announces updates on pandemic influenza program

The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines


Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution
News | January 18, 2025

Indegene wins 2025 BIG Innovation Award for Hyper-automated AI solution

Hyper-automated AI is a unified framework combining AI, ML, RPA, and NLQ to streamline data extraction, quality management, transformation, and actionable insights - all on a single platform


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


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


Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
News | January 16, 2025

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business


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


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure


Genome India Project marks a defining moment for country's biotechnology landscape: Modi
Policy | January 11, 2025

Genome India Project marks a defining moment for country's biotechnology landscape: Modi

Modi remarked that more than 20 illustrious research institutions such as IISc, IITs, CSIR and DBT-BRIC have played a major role in this research


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


Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments
Diagnostic Center | January 09, 2025

Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments

The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life