Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

The US Food and Drug Administration (FDA) has issued a Warning Letter to Aurobindo Pharma for its drug-manufacturing facility in Srikakulam District, Andhra Pradesh, India, citing deviations from current good manufacturing practice (cGMP) for...

Pfizer has announced the election of Scott Gottlieb, MD, the former US Food and Drug Administration (FDA) Commissioner, to its Board of Directors, effective with its announcement on June 27, 2019. Dr. Gottlieb was also appointed to the Regulatory...

Glenmark Pharmaceuticals, a generics pharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding manufacturing issues relating to its new drug application (NDA) for Ryaltris...

Akorn, a specialty generic pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) related to an inspection by the FDA of its Somerset, New Jersey manufacturing facility conducted in July and August...

The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Sun Pharmaceutical Industries following a pre-approval inspection of the company’s facility in Halol, Gujarat, India, which was from June 3, 2019 to June 11,...