Another last-minute Trump administration policy was issued at the end of last week by HHS that requires five-year, renewable term limits for directors of all agencies under the department, including…
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in…
Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle…
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Source: Drug Industry Daily
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving…
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan…
The FDA’s vaccines advisory committee voted almost unanimously on Thursday in favor of Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, with all but one abstaining member supporting clearance, and…
With COVID-19 cases surging across Europe, EC President Ursula von der Leyen announced yesterday that EU countries will start vaccinations with the two-dose Pfizer/BioNTech vaccine on Dec. 27. Source: Drug…
Novartis has agreed to buy Cambridge, Mass.-based Cadent Therapeutics for a possible $770 million, expanding its pipeline of treatments for cognitive and mood disorders. Source: Drug Industry Daily
In a Thursday hearing of a congressional committee, two members of the Sackler family and Purdue Pharma’s current president and CEO, Craig Landau, dutifully expressed sorrow for the role played…