The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and tracheostomy tubes that enter the airway through the neck. The agency categorized each of them as Class I recalls, its most serious type.

To help clinical trial sponsors who are planning global cancer studies best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in oncology. The draft includes considerations for selecting clinical trial sites, analyzing data and incorporating regional information about the disease and available treatments.

Biohaven has linked troriluzole to a significant slowing of progression in an ultra-rare disease, setting the biotech up to take another shot at winning approval with an asset that the FDA refused to review last year.

AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate (ADC) has again failed to improve overall survival (OS) in a phase 3 trial. The latest miss happened in breast cancer, a setting in which Gilead Sciences’ rival Trodelvy significantly improved OS in a prior late-phase study.

Cataract removal is one of the oldest and most common surgeries in the world. A surgeon makes small incisions in the eye, sucks out the cloudy lens and replaces it with an artificial lens implant. Complications are rare but can range from blurred vision and light sensitivity to retinal detachment, which can lead to blindness if untreated.

Novo Nordisk’s $1 billion bet that it had found a cannabinoid CB1 receptor blocker that could reduce weight while avoiding the psychiatric effects that capsized Sanofi’s Acomplia faces questions after the company revealed mid-stage headline results.

Slow enrollment in a key clinical trial has driven Genfit to rework the protocol to try to keep the study on track. The biotech said the changes reflect the comorbidities of people with acute on-chronic liver failure (ACLF) and the logistics of caring for the patients.

Sanofi has shared data from the phase 3 HERCULES trial that could rescue its multiple sclerosis (MS) drug candidate tolebrutinib, linking the BTK inhibitor to a 31% delay in time to onset of confirmed disability progression. The drugmaker plans to seek approval this year.

Edgewise Therapeutics’ hypertrophic cardiomyopathy (HCM) asset has started off with a bang after early safety data sent the company’s shares soaring.

William McEwan, Ph.D., spent years unraveling how an antiviral protein, tripartite motif-containing 21 (TRIM21), protects our cells from infection. Working in the lab of Leo James, Ph.D., McEwan and collaborators realized that TRIM21 marks viruses to be destroyed by the cell’s waste disposal system—but only activates when enough of the proteins cluster together.