FDA investigating Elevidys safety; Nektar shares spike on eczema data

The agency said it will evaluate whether regulatory action is needed after investigating the deaths of two patients treated with Sarepta's therapy.

By BioPharma Dive staff • June 24, 2025

Cassidy challenges RFK Jr. with call for delay to CDC vaccine meeting

The GOP senator objected to Secretary Kennedy's recasting of the influential advisory panel, which has sparked criticism from medical groups and Democratic lawmakers.

By Delilah Alvarado • Updated June 24, 2025

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

New Amgen obesity drug data disappoint Wall Street

Full Phase 2 study results showed side effects that led people to stop treatment with MariTide, as well as weight loss effects that weren’t as strong as previously reported.

By Jonathan Gardner • June 24, 2025

Novo abruptly ends obesity drug deal with Hims

The Wegovy maker says the telehealth company didn't stop selling compounded versions of the blockbuster drug after Novo resolved its shortage.

By Jonathan Gardner • Updated June 23, 2025

The rise of GLP-1 drugs: Transforming weight loss treatment

Discover how GLP-1 drugs are reshaping weight loss and treatment horizons.

By Federica Maggiorelli • June 23, 2025

FDA to speed reviews for drugs supporting ‘national interests’

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

By Jonathan Gardner • Updated June 18, 2025

Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

The Swiss drugmaker said it was “encouraged” by the signs of effectiveness of the drug, developed by biotech Prothena, showed in two earlier studies that missed their main goals.

By Jonathan Gardner • June 16, 2025

Novo, searching for a spark, plans late-stage trials for amylin drug

The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an obesity medication that works differently than its popular Wegovy. 

By Jonathan Gardner • June 13, 2025

RFK Jr. reveals picks for influential vaccine panel

Days after firing all 17 members of the CDC's Advisory Committee for Immunization Practices, the HHS Secretary named a small new committee that includes multiple vaccine critics.

By Kristin Jensen • June 12, 2025

Pharma’s wins and losses in the budget bill

Key pharma reforms are up in the air as Republicans battle over their mammoth legislation that includes significant healthcare spending cuts.

By Amy Baxter • June 12, 2025

Bristol Myers bolsters radiopharma portfolio with PhiloChem deal

The company is paying $350 million upfront, and potentially over $1.3 billion overall, for a radiopharmaceutical for prostate cancer that works differently than Novartis’ Pluvicto. 

By Kristin Jensen • June 11, 2025

Vaccine makers face fresh uncertainty after firing of CDC panel

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned with Robert F. Kennedy Jr.’s skeptical views, analysts warned.

By Delilah Alvarado • June 10, 2025

Merck antibody drug for RSV approved by FDA

Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly became a blockbuster medicine following its approval two years ago.

By Delilah Alvarado • June 9, 2025

Merck claims study success with PCSK9 cholesterol pill

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair of closely watched trials.

By Ben Fidler • June 9, 2025

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

By BioPharma Dive staff • June 6, 2025

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

Enhertu, Datroway and other antibody-drug conjugates developed by Daiichi Sankyo have made the company a leader in a competitive field. Hiroyuki Okuzawa is working to keep it that way.

By Ned Pagliarulo • June 4, 2025

Lilly partners with Camurus in search of a long-lasting obesity drug

The deal, which could be worth up to $870 million overall, will give Lilly access to a delivery technology that may help extend the durability of up to four of its weight-loss medicines.

By Kristin Jensen • June 4, 2025

Regeneron makes obesity push; Atai, Alto ink brain drug deals

Regeneron licensed a weight loss drug and revealed study data for a pair of muscle-preserving medicines. Elsewhere, two neuroscience biotechs cut deals and Bluebird officially went private.

By BioPharma Dive staff • June 4, 2025

Merck, Daiichi pull approval application for ADC in lung cancer

A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.

By Ben Fidler • May 29, 2025

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

Agile biopharma firms are driving breakthroughs. Learn how they ensure clinical trial success in this podcast.

By BioPharma Dive's studioID • May 28, 2025

Biogen strikes RNAi deal with City; Aurion withdraws IPO

City will receive $46 million from Biogen under the alliance. Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug.

By BioPharma Dive staff • May 27, 2025

Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.

By Jonathan Gardner • May 22, 2025

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

By BioPharma Dive staff • May 22, 2025

FDA panel backs Darzalex for early stage multiple myeloma

Agency drug reviewers had questioned patient risk criteria and the efficacy endpoint used in a key trial supporting J&J's drug.

By Jonathan Gardner • May 21, 2025

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

Tourmaline Bio disclosed results for a potential rival to a Novo Nordisk drug. Elsewhere, data emerged for a psychedelic and CRISPR Therapeutics expanded its toolkit.

By BioPharma Dive staff • May 20, 2025