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The antibody therapy received emergency authorization in December for treating immunocompromised people 12 years and older who may be unable to mount a proper immune response to a COVID-19 vaccine. Read More
The European Medicines Agency’s (EMA) human medicines committee gave a thumbs up to 13 new drugs, including two biosimilars and five generics, in its monthly meeting last week. Read More
The FDA has sent Mumbai-based Macleods Pharmaceuticals a 19-page, seven-observation Form 483 outlining many issues related to the cleanliness of its manufacturing facility after an inspection in October and November of 2021. Read More
Jardiance (empagliflozin), the type 2 diabetes and cardiovascular blockbuster developed by Eli Lilly and Boehringer Ingelheim, has expanded its indications with a new approval for reducing the risk of cardiovascular death and hospitalization in adults with heart failure and preserved left ventricular ejection fraction (LEVF). Read More
The FDA outlined its latest thinking on patient-focused drug development in a final guidance released on Friday, including ways to gather information that can be used for trial design. Read More
Johnson & Johnson (J&J) and three drug wholesalers have reached a deal to pay out $26 billion to settle thousands of lawsuits over their business practices, which plaintiffs claim fueled the deadly opioid crisis over the past two decades. Read More
The FDA “has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility,” said the warning letter. Read More
The CDC stressed that a shorter period between a first and second shot is recommended for those who are immune-compromised, adults who are 65 years old and up and those who are at greater risk of severe disease or who require immediate protection because of where they work. Read More