The drug’s developer, Amylyx Pharmaceuticals, said the meeting is scheduled for Sept. 7 and experts will discuss additional data analyses conducted since the last time the panel met.

An entity originally known as Teneobio has now been the focus of three acquisition deals with large pharmaceutical companies since 2021, capitalizing on the industry’s growing interest in dual-acting antibody drugs.

The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.

New study results show the medicine appears as effective, or stronger, than standard care for chronic urticarias, a common condition that drugs from Regeneron and Novartis have struggled to treat.  

Data compiled by BioPharma Dive show a growing gap in the frequency and size of new offerings compared to prior years. Some analysts believe as many as a third of public biotechs must “go away” before the sector’s slump ends.

A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a potential lack of potency against new variants.

The order will bolster the government stockpile of COVID-19 vaccines ahead of a booster rollout that the FDA now says should include shots tailored to the newest versions of omicron.  

Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

Amid a historic market downturn, the precision drug company is raising money through royalty financings with Sixth Street and Royalty Pharma.

A regimen involving its drug Imfinzi improved tumor responses when given before surgery, building on evidence that immunotherapies, already mainstays for advanced disease, could become standard treatments earlier.  

The two drugmakers joined a long list of investors, including Pfizer and Sanofi, that have been funding the startup’s plan to develop a new type of lipid nanoparticle technology. 

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.