Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity

Tulasi Healthcare Introduces dTMS Therapy service for Treatment-Resistant Depression

Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive brain stimulation technique approved by regulatory authorities, including the USFDA

Boehringer Ingelheim receives FDA approval for Senvelgo to treat diabetes in cat

Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus

USFDA completes PAD E inspection of Marksans' Goa facility

The inspection was conducted at its Goa, Vema manufacturing facility

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease