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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, poor building condition and other lapses. Read More
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 the American Society of Hematology (ASH) Annual Meeting in New Orleans. Read More
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 future revenue-drivers. Read More
For the Moderna option, children between six months and five years old can receive a single bivalent booster dose two months after completing the primary series. Read More
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large-volume parenterals (LVP) to ensure PN products do not exceed the recommended daily limit, according to a new FDA draft guidance that clarifies key factors in determining the aluminum content in SVPs. Read More
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). Read More
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 shingles-related injuries. Read More
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. Read More