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5723 News Found

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


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


Apotex acquires US rights to PROVIGIL and NUVIGIL
News | January 13, 2025

Apotex acquires US rights to PROVIGIL and NUVIGIL

PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy


Zaynich achieves over 97% efficacy in clinical study for meropenem-resistant gram-negative pathogens
Clinical Trials | January 13, 2025

Zaynich achieves over 97% efficacy in clinical study for meropenem-resistant gram-negative pathogens

The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure


Iconovo and Lonza to collaborate on formulation development of an intranasal biologic
News | January 13, 2025

Iconovo and Lonza to collaborate on formulation development of an intranasal biologic

Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)


Aragen secures $100 million investment from Quadria Capital
News | January 13, 2025

Aragen secures $100 million investment from Quadria Capital

Investment will fund expansion to meet rising demand for CRDMO services


Synaffix and Mitsubishi Tanabe Pharma ink license agreement for ADC technology
News | January 10, 2025

Synaffix and Mitsubishi Tanabe Pharma ink license agreement for ADC technology

Usage of Synaffix GlycoConnect, HydraSpace and toxSYN ADC technologies to enhance efficacy, tolerability and target engagement


Windlas Biotech’s new injectable facility receives GMP certification
News | January 10, 2025

Windlas Biotech’s new injectable facility receives GMP certification

The certification marks a new chapter in Windlas Biotech’s growth trajectory,