Novartis is suing Regeneron for patent infringement over the manufacturing process of its Eylea and Zaltrap eye treatments.

The FDA has issued India's Malladi Drugs & Pharmaceuticals a warning letter and banned its products from the U.S. until it can vastly improve.

Indian drugmaker Dr. Reddy’s said that following an inspection, the FDA issued a Form 483 to its API Hyderabad Plant 1, citing four issues.

The problems at a Celltrion plant that threaten Teva's fremanezumab launch may be less limited than the company had hoped, analysts say.

Amid the opioid crisis in the U.S., physicians and hospital pharmacists are having increasing difficulty finding injectable painkillers.

Sagent Pharmaceuticals issued the recall after detecting higher-than-specified impurities during routine quality testing.

Jerrod Nichols Smith, one of three people indicted in 2013 for a drug wholesaling scam in Tennessee, was convicted last week of 15 counts of mail fraud and one…

Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.