Lilly to submit obesity pill after hitting goal in third late-stage trial

In people with diabetes and obesity, orforglipron led to weight loss near what people without diabetes experienced in prior testing.

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

AbbVie wagers more than $1B on Gilgamesh’s psychedelic drug

The asset deal thrusts AbbVie to the forefront of the psychedelic field, handing it a therapy that recently scored positive Phase 2 results in major depression.

FDA suspends license for Valneva’s chikungunya shot

The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no longer safe for its intended use.

Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales

An $885M deal with BeOne Medicine gives the pharma financier rights to a revenue stream from global sales of Imdelltra, which is sold by Amgen.

FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

FDA cancels adcomm on Biohaven drug; Catalent lays off staff

Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff at a gene therapy facility.

Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius

The deal gives Gilead ownership of a technology that can genetically modify immune cells inside the body, an approach could that potentially widen access to CAR-T treatment.

FDA approves Ionis’ hereditary angioedema drug

Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition. Ionis set its list price at $57,462 per dose.

Updated Aug. 21, 2025

US, EU agree to terms of framework trade pact

The countries documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, pharmaceuticals and semiconductors.

Sarepta pushes off debt payments in bid to regain financial footing

A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its pipeline and meet its near-term financial obligations, CEO Doug Ingram said. 

Xoma, a drug royalty specialist, buys another ‘zombie’ biotech

A deal to acquire Alkermes spinout Mural Oncology is Xoma’s fourth since June and the latest evidence of interest in buying and shutting down struggling drugmakers.

Lilly searching for new neuro chief as White set to retire

Anne White, a 30-year company veteran who previously led the company’s oncology unit, will step down as head of Lilly Neuroscience at the end of December.

Rocket can resume gene therapy trial after FDA lifts hold

The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died earlier this year.

MAHA may take aim at pharma DTC ads

RFK Jr. has his sights set on increasing oversight and enforcement against drugmakers that run afoul of advertising laws.

CSL to separate vaccine business, cut jobs

On an earnings call, CSL CEO Paul McKenzie described weakness in the U.S. market for seasonal flu vaccines as “disappointing” and “highly irrational.”

PTC drug for Friedrich’s ataxia rejected; Lilly sells nearly $7B in bonds

The FDA said data for PTC's drug did not prove "substantial evidence of efficacy." Elsewhere, the FDA delayed its decision on a Regenxbio gene therapy and Skyhawk Therapeutics struck a deal.

Viking shares sink as obesity pill misses expectations in key study

The company’s market value was nearly cut in half following trial results showing higher rates of treatment discontinuations among people receiving Viking’s drug. 

Kennedy’s mRNA cuts could set US science back, experts warn

Scientists say HHS’ decision to defund mRNA vaccine research will leave the country less prepared for pandemics, and make it harder to invest in companies advancing the technology.

Reunion’s psychedelic drug headed to late-stage testing

The drug, which functions similar to psilocybin, scored positive enough results in a mid-stage study that Reunion is now setting up a larger experiment to hopefully secure approval in postpartum depression.

Stealth resubmits rare disease drug to FDA

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency’s concerns and now sees potential for a speedy review.

Novo’s Wegovy becomes first GLP-1 drug approved for MASH

The FDA clearance sets Novo’s medicine up for a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

Precigen wins immunotherapy approval; Pfizer sickle cell drug fails trial

The FDA’s announcement of Papzimeos’ approval contained an unusual quote from newly reinstated CBER director Vinay Prasad. Elsewhere, Eli Lilly and Superluminal Medicines struck a deal.

Merck KGaA ventures into new territory in the US

Miguel Fernández Alcalde, head of Merck KGaA’s U.S. arm, aims to “double down” on innovation. The company’s recent SpringWorks deal is just a start.

HHS revives defunct task force on childhood vaccine safety

The panel’s reinstatement is one of a series of controversial moves made by Robert F. Kennedy Jr. to put vaccines under new scrutiny.