An “untitled” letter from the FDA requires the same level of response as a warning letter, says one former FDA compliance director. Source: Drug Industry Daily

An FDA inspection of Consolidated Chemical’s St. Louis, Mo., drug manufacturing facility from July 25 to Aug. 2 resulted in a Form 483 citing water leaks, lack of water testing,…

Two potentially first-in-class small molecule oral agents induced complete remission in nearly 30 percent of patients with genetically induced leukemias generally associated with very poor prognoses, according to reports from…

In the biggest pharmaceutical purchase announced this year, Amgen has inked a $28 billion deal with Horizon Therapeutics, gaining access to one blockbuster eye drug and two others that are…

Manufacturers of parenteral nutrition (PN) products should determine the amount of aluminum in small-volume parenterals (SVP) as well as large-volume parenterals (LVP) to ensure PN products do not exceed the…

The FDA issued a 10-observation Form 483 to Aurobindo’s Telangana, India, plant after a November visit, outlining several violations of current good manufacturing practices (cGMP). Source: Drug Industry Daily

Four years into a multidistrict class action lawsuit, a federal court judge has dismissed 1,189 of the 2,000 lawsuits charging that Merck’s Zostavax shingles vaccine caused either the disease or…

FDA Commissioner Robert Califf predicts the agency’s largest area of expansion over the next five years will be in the regulatory apparatus for reviewing cell, regenerative and gene therapies. Source:…

The FDA has added a Sun Pharmaceutical facility in Gujarat, India, to an import alert following an agency inspection, but is exempting 14 products to avoid potential shortages. Source: Drug…

The FDA rapped independent testing lab Valisure in an untitled letter for violating the Drug Supply Chain Security Act (DSCSA) and for “methodological deficiencies” in its testing protocols, disputing the…