Metagenomi is laying of 25% of its staff while switching up leadership. Elsewhere, Ovid announced a CEO succession plan and Cogent Biosciences and Galecto saw their shares skyrocket. 

The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of the “lingering uncertainties” surrounding the FDA, wrote one industry...

Analysts suspected that the mid-stage trial miss wouldn't ding Neurocrine’s share price since expectations around the program were "near-zero."

The decision, issued without the input of an official advisory committee, revises long-held labeling on the drugs cautioning the risk of cancer and heart disease.

The drug appears effective against both “relapsing” and “primary progressive” forms of the disease, though some analysts question if Roche has collected enough data to ask for approval in the latter.

Merck’s pill, which could be the first oral PCSK9 drug to get to market, displayed similar effects on lipid levels as injectable medicines from Amgen and Regeneron.

The alliance extends a deal streak in genetic medicine for Lilly and hands the company rights to an experimental treatment for an ultra-rare form of childhood blindness.

The agreement will make Wegovy and Zepbound available to some Medicare enrollees for $245 per month, and starter doses of pill versions, once approved, for $149 monthly.

The pharma giant disclosed in an earnings report that it paid $170 million up front to acquire SixPeaks Bio, a weight loss-focused startup it helped launch last year.

Despite quarterly revenue totals that were nearly cut in half compared to the same period last year, Moderna still expects to break even financially in 2028 with the help of more disciplined spendi...

The immune drugmaker is the second biotech, along with MapLight Therapeutics, to recently use a workaround in U.S. securities law to price an offering during the shutdown. 

Caplyta, which J&J got in its acquisition of Intra-Cellular Therapies, netted a clearance in major depressive disorder that’s key to achieving the $5 billion in annualized sales the company expects.

Soleno shares fell double digits amid questions about the growth trajectory of its Prader-Willi drug. Elsewhere, a cancer medicine at the center of a $1.9 billion buyout fell short in a key trial. 

The brain drug developer plans to slash R&D expenses by about 60% in the wake of the FDA surprisingly rejecting its rare disease drug Vyglxia.

Ahead of a reported White House deal meant to lower the cost of obesity drugs like Wegovy, Novo said “intensifying competition and pricing pressure” led it to lower its yearly sales projections.

The startup is advancing a drug licensed from China’s Hengrui Pharma that it claims could be “best-in-class” among a group of similar treatments for hypertrophic cardiomyopathy.

The obesity drug developer has declared a new proposal from Novo “superior” to Pfizer’s original bid as well as an updated offer revealed Tuesday.

The deal hands Blackstone a piece of the potential future sales of an antibody-drug conjugate that could soon challenge marketed medicines from AstraZeneca and Gilead.

While the launches of Journavx and Casgevy have started to build steam, “investors may not be inclined to look past the clear revenue misses,” wrote a Raymond James analyst.

Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and that the evidence accrued to date makes a strong case for full approval.