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.

By Jacob Bell • Aug. 18, 2025

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.

By Ben Fidler • Aug. 18, 2025

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

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.

By BioPharma Dive staff • Aug. 15, 2025

Vedanta, PureTech’s microbiome startup, to cut staff after study setback

The result marks the latest failure for a microbiome therapy in inflammatory bowel disease, which has long been a top target of Vedanta and other companies like it.

By Ben Fidler • Aug. 14, 2025

PureTech launches new biotech built around lung disease drug

The spinout, known as Celea Therapeutics, will advance what’s designed to be an improved version of the drug pirfenidone for idiopathic pulmonary fibrosis. 

By Delilah Alvarado • Aug. 12, 2025

Bayer buys into KRAS cancer drug; Novartis immune therapy goes 3 for 3

The German pharma will license a KRAS G12D inhibitor from Kumquat Biosciences. Elsewhere, a Biohaven OCD drug missed its study goal, while Biogen and Stoke began a key Phase 3 test.

By BioPharma Dive staff • Aug. 12, 2025

Expedition, a startup searching for drugs from China, cuts its first deal

The startup agreed to pay Fosun Pharma as much as $645 million for a drug in testing for multiple lung conditions, including bronchiectasis.

By Ben Fidler • Updated Aug. 12, 2025

IO Biotech sees path forward for skin cancer vaccine despite study setback

A regimen involving the company’s shot failed a Phase 3 trial “by a hair,” an executive said, leading the company to believe it still could win U.S. approval.

By Jonathan Gardner • Aug. 11, 2025

As gene therapy sales sputter, one biotech aims to defy the odds

With a strong launch underway for a bladder cancer gene therapy, Ferring is finding the kind of commercial success that’s eluded many of its peers.

By Meagan Parrish • Aug. 11, 2025

Vinay Prasad, in surprise reversal, to rejoin FDA after abrupt departure

One analyst speculated that, going forward, Prasad may be less “heavy-handed” in reviewing rare disease therapies given the public backlash to the agency’s confrontation with Sarepta.

By Ben Fidler • Updated Aug. 11, 2025

BioNTech ends patent fight with mRNA rival CureVac ahead of buyout deal

The complex settlement, which hands payouts and royalties to CureVac and partner GSK, comes as BioNTech is inching toward an acquisition of its one-time COVID-19 vaccine competitor.

By Jonathan Gardner • Aug. 8, 2025

Elevidys sales weaken; Neumora gets into obesity

Sarepta reported a quarter-on-quarter dip in sales for its Duchenne gene therapy. Elsewhere, Jazz won FDA approval of a brain cancer drug and Novo decided to advance a Prothena medicine into Phase 3.

By BioPharma Dive staff • Aug. 8, 2025

Strand raises another $153M to make ‘programmable’ mRNA drugs

The fundraise will help advance a cancer therapy that’s already shown early promise in people whose cancers haven’t responded to drugs like Keytruda.

By Gwendolyn Wu • Aug. 7, 2025

Arvinas, Pfizer reworking partnership on ‘Protac’ cancer drug

The smaller market now envisioned for vepdegestrant has changed both companies’ stance on their original deal, leading to negotiations that could either lead to a new alliance or Arvinas to seek a new partner. 

By Kristin Jensen • Aug. 7, 2025

Iovance cuts staff amid slow sales start for ‘TIL’ cell therapy

In its latest earnings report, Iovance confirmed plans to reduce its workforce by 19% in a bid to save $100 million in yearly costs.

By Ben Fidler • Updated Aug. 8, 2025

HHS abandons mRNA vaccine research

One vaccine expert called the move, which cancels some $500 million in messenger RNA research contracts, a “giant step backward for science.” 

By Delilah Alvarado • Aug. 6, 2025

Nxera debuts an obesity pipeline; BridgeBio battles Alnylam for market share

The company formerly known a Sosei Heptares unveiled new weight loss programs. Elsewhere, BridgeBio and Madrigal unveiled sales numbers for their chief drugs.

By BioPharma Dive staff • Aug. 6, 2025

US biotech needs government support to match China’s gains, Pfizer CEO says

“The biotech industry needs to be supported by the government, by Congress,” Pfizer’s Albert Bourla told investors in Aug. 5 comments on China’s rising competitiveness.

By Ben Fidler • Aug. 5, 2025

David Altshuler, geneticist who helped transform Vertex, to retire next year

Since becoming Vertex's top scientist in 2015, Altshuler has shaped the company’s efforts to expand beyond cystic fibrosis.

By Ben Fidler • Aug. 5, 2025

Gates Foundation pledges $2.5B to women’s health research

The investment, which the foundation says is its largest in women’s health, will support research in maternal health, obstetric care and sexually transmitted infections, among other areas.

By Delilah Alvarado • Aug. 4, 2025

Xoma strikes deals to buy struggling biotechs HilleVax, Lava

The royalty aggregator’s proposed deals for HilleVax and Lava add to a pattern of “zombie” biotech buyouts this year as the sector’s struggles continue.

By Gwendolyn Wu • Aug. 4, 2025

Regeneron cancer bispecific rejected again; Allogene discloses trial death

The FDA issued a complete response letter for Regeneron's lymphoma drug odronextamab. Elsewhere, Bristol Myers raised its guidance and analysts saw progress in Biogen’s turnaround.

By BioPharma Dive staff • Aug. 1, 2025

Alnylam reaches new highs on strong sales of closely watched rare disease drug

Despite battling drugs from BridgeBio and Pfizer, Amvuttra beat Wall Street expectations with results Alnylam’s CEO claimed were “not a flash in the pan.”

By Ben Fidler • July 31, 2025

Venture firm Frazier closes $1.3B fund for early-stage biotech investing

Frazier was among the most active venture investors in 2024, according to analysts at William Blair, backing 17 private life sciences companies.

By Gwendolyn Wu • July 31, 2025

Moderna to lay off 10% of workforce in ‘difficult but necessary step’

In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the “realities of our business.”

By Delilah Alvarado • July 31, 2025