BridgeBio Pharma (BBIO) said the US Food and Drug Administration has accepted its New Drug Application for encaleret, an oral therapy for autosomal dominant hypocalcemia type 1, with a target action date of May 8, 2027.

Argenx (ARGX) has agreed to acquire Forte Biosciences (FBRX) for approximately $2.2 billion, adding the experimental autoimmune therapy FB102 to its portfolio.

Roche (RHHBY) has unveiled plans for a pivotal trial of its experimental Alzheimer's antibody, seeking to demonstrate it can prevent symptoms from developing as the Swiss drugmaker races Eli Lilly (LLY) and Japan's Eisai (ESAIY) to push the disease's treatment frontier from therapy into prevention.

AstraZeneca (AZN) has agreed to pay $600 million upfront to license a lung cancer treatment from China's Dizal Pharmaceutical (688192.SS), sending shares in the Shanghai-listed spinoff surging 20 percent.

Biogen (BIIB) said that the lowest dose of its experimental Alzheimer's drug diranersen reduced cognitive decline across five of six standard assessment tools and cut levels of a toxic brain protein by up to 65%, even as the treatment missed its primary goal in a mid-stage clinical trial.

Insulet (PODD), the maker of the Omnipod wearable insulin patch, has teamed up with mental health app Calm to launch a suite of free mindfulness resources tailored specifically to people living with diabetes, in what the companies describe as Calm's first integrated content partnership with a medical device manufacturer.

Yum Brands (YUM) said that its Taco Bell chain had pulled a limited number of items from select restaurant locations as a precautionary measure, even as US health officials stopped short of linking the fast-food chain to a widening outbreak of cyclosporiasis that has now spread across 34 states.

Shares of BridgeBio Pharma (BBIO) surged to a 52-week intraday high of $93.42 earlier in the month before closing the session 15% higher, adding roughly $2.3 billion in market value, after AstraZeneca (AZN) disclosed a late-stage clinical failure that investors believe strengthens BridgeBio's position in the market for a rare heart condition.

The US Food and Drug Administration has approved gedatolisib, the first drug to reach market for Minneapolis-based Celcuity (CELC), granting the green light for a treatment targeting an advanced form of breast cancer in which existing options remain limited.

A coalition of public health organizations, pediatricians and parents filed suit against the U.S. Food and Drug Administration on Tuesday, challenging a policy they say allows vape manufacturers to sell products without the marketing authorization required under federal law.