ProKidney has stopped one of a pair of phase 3 trials for its cell therapy for kidney disease after deciding it wasn’t essential for securing FDA approval.

Pfizer and Valneva may have about two more years to wait before they make the first approval filing to the FDA for a Lyme disease vaccine, but that hasn’t stopped the companies collecting more positive data in the meantime.

A study from Abbott found that employing its cardiac valve repair implant during earlier phases of heart failure—when a patient’s leaky mitral valve is still considered to be functional—could lead to fewer related hospitalizations while improving health status and quality of life.

The FDA has approved a new type of stent designed specifically for infants and young children—including neonates born with congenital heart defects—that’s designed to expand in size as the child grows.

ReNeuron has joined the long list of biotechs to leave London’s AIM stock market. The stem cell biotech is letting go of its listing after money troubles persuaded it to free itself from the costs and regulatory obligations of the exchange.

Shanghai Allist Pharmaceuticals has bought itself a starring role in China’s KRAS market, paying Jacobio Pharma 150 million Chinese yuan ($21 million) for rights to a near-approval inhibitor of the oncogene and a potentially complementary molecule.

NuCana has seen another of its reworked chemotherapies struggle to prove itself in the clinic, halving the biotech’s stock in post-market trading.

The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the Biden administration to ensure the safety and security of machine learning software.

Proteins are made of chains of amino acids, and a basic tenet of biology is that the sequence of amino acids determines how a protein folds into a 3D shape which, in turn, dictates the protein’s function. But another tenet of biology is that rules are meant to be broken.

The effort to develop psychedelic therapies took a hit earlier this month when the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy, a blow that was quickly followed by the retraction of three Lykos research papers and the slashing of 75% of the biotech’s workforce.