FDA clinical holds saw a sharp increase in 2021, propelled in large part by holds on cell and gene therapy trials, according to an analysis by investment banking firm Jefferies…

Amryt Pharma received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Oleogel-S10 for treating a rare genetic skin ailment — epidermolysis bullosa (EB).…

Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay…

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. Source: Drug…

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…

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…

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. Source:…

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 FDA has issued a third Complete Response Letter (CRL) to Mallinckrodt for the company’s investigational drug terlipressin for the treatment of adults with hepatorenal syndrome (HRS), a life-threatening syndrome…

Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in…