Tristan Manalac

Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner's National Priority Voucher initiative.

Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology's darlifarnib plus Bristol Myers Squibb's Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech.

The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.

Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.

Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirror that of Eli Lilly's: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide.

The antisense oligonucleotide was even more effective in patients with relatively low viral activity. More than one-quarter of these individuals had undetectable levels of the virus in the blood for at least six months after stopping treatment.

Pfizer continues its dealmaking spree by striking a back-heavy partnership with China's Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer.

Beren Therapeutics is seeking approval in Neimann-Pick disease type C, an application the FDA was set to decide on by August 17. The new target action date is November 17.

Replimune's resubmission for RP1 for melanoma comes amid the departures of FDA leaders in place at the time of the drug's first two rejections, last summer and again in April.

The American Diabetes Association's annual congress will feature a superstar lineup, including weight loss giants Eli Lilly and Novo Nordisk. But several scrappy biotechs will also present obesity candidates with the potential to match—if not outperform—their deep-pocketed competitors.