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VLA15, the only Lyme disease jab in clinical development, works by targeting the outer surface protein of Borrelia burgdorferi, the bacteria responsible for causing the disease. Read More
The FDA needs to hire more investigators to conduct overseas inspections to reverse a decline in foreign site visits, the Government Accountability Office (GAO) said in a report released yesterday. Read More
Two research groups at odds over who invented the game-changing CRISPR gene-editing technology appeared before the U.S. Patent and Trademark Office (USPTO) on Friday to argue their cases. Read More
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
FDA’s top cancer specialist is already waving a red flag at sintilimab, saying the Eli Lilly-licensed Chinese oncology drug — scheduled for review by an FDA advisory committee this week — might not be suitable for a U.S. approval based on its single-country pivotal trial data. Read More
As his confirmation to the top spot at the FDA hangs precariously in the balance, Robert Califf seems to be making a lot of concessions to lawmakers even as support for his nomination from the medical community and the industry swells. Read More
The company wants to shift focus away from when exactly it will seek accelerated approval since the commercial impact is likely to be limited, said Daniel Skovronsky, Lilly’s chief scientific officer. Read More