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

DBT hosts webinar on Biomanufacturing for Climate Resilient Agriculture

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

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance

Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer

If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population

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

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

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

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

Investment will fund expansion to meet rising demand for CRDMO services