Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for…
Merck’s investigational chronic cough drug, gefapixant, won Japanese approval last week, but this week didn’t make FDA’s approval cut. Source: Drug Industry Daily
As the Omicron variant continues to spread rapidly, the FDA has granted accelerated approval to Gilead Sciences for Veklury (remdesivir), the first FDA-approved COVID-19 treatment for patients outside hospitals who…
Kura Oncology said Friday that the FDA has lifted a partial clinical hold placed on the company’s early-stage clinical trial of its drug candidate, KO-539, in patients with relapsed or…
The UK’s National Institute for Health and Care Excellence (NICE), the body that evaluates medicines for use by the National Health Service (NHS), is changing the way it makes judgments…
A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday.…
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through…
The next FDA commissioner — most likely Robert Califf, who is now awaiting a confirmation vote by the Senate — will face a tough 2022 on multiple fronts, beyond just…
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Source:…
In oral arguments held Wednesday, Sanofi urged a federal appeals court to reconsider its complaint against Mylan (now Viatris) over allegations the latter engaged in anticompetitive practices to maintain its…