Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.

By Kristin Jensen • April 10, 2025

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Amid a funding drought for startups, the company is looking for a deal that can advance its liver cancer drug.

By Jonathan Gardner • April 10, 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 or in reprogramming cells inside the body.

By BioPharma Dive staff

Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division

In its first full year on the U.S. market, bladder cancer treatment Adstiladrin earned about $77 million. Elsewhere, Lilly backed a cancer drug startup and Bristol Myers won a new Opdivo approval.

By BioPharma Dive staff • April 9, 2025

US risks losing biotech edge to China, report warns

“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the April report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

By Ned Pagliarulo • April 8, 2025

Rallybio discontinues lead drug for rare maternal disorder

The company has decided to switch gears following disappointing data for a monoclonal antibody targeting a rare maternal blood disorder.

By Delilah Alvarado • April 8, 2025

Tango Therapeutics cuts nearly one-fifth of staff

“We, like so many others, have been forced to take steps to extend our cash runway,” said Tango’s CEO, citing “extremely challenging financial markets.”

By Gwendolyn Wu • April 7, 2025

Obesity drug data helps Rhythm defy market slide

Study results in a rare form of obesity could help the company expand use of Imcivree, which is approved for two genetically driven forms of excess weight.

By Jonathan Gardner • April 7, 2025

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a buyout and high-dose Ocrevus missed a study goal.

By BioPharma Dive staff • April 4, 2025

FDA misses approval deadline for Novavax’s COVID-19 vaccine

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter Marks.

By Delilah Alvarado • April 3, 2025

Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

More than three-quarters of private biotech investment tracked by BioPharma Dive between January and March was distributed via rounds worth at least $100 million, which experts believe reflects a strategic shift.

By Gwendolyn Wu • April 3, 2025

Leqembi’s EU review drags on; Sanofi gets a new development head

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of insolvency and Novartis hired a new top lawyer.

By BioPharma Dive staff • April 2, 2025

New genetic medicine CDMO acquires Landmark Bio

Artis BioSolutions joins a host of startups trying to improve development and manufacturing capacity for cutting-edge gene and cell therapies.

By Kristin Jensen • April 2, 2025

RNA editing biotech Airna adds $155M in funding

Airna will use the Series B round to launch a Phase 1/2 trial of its lead program for alpha-1 antitrypsin deficiency, a disease targeted by several other firms.

By Gwendolyn Wu • April 1, 2025

Isomorphic raises $600M on big ambitions for AI drugmaking tech

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and predict molecular structures.

By Gwendolyn Wu • March 31, 2025

FDA official’s ouster sends shares of vaccine makers sliding

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

By Delilah Alvarado • March 31, 2025

How discoverable, comparable and explorable is your data?

Accelerate biomarker research with high-quality, expert-curated data to drive precision medicine.

By QIAGEN Digital Insights • March 31, 2025

Novo gains Lexicon obesity drug; CRISPR COO to step down

Novo is paying up to $1 billion for a “non-incretin” medicine that might boost Wegovy’s effects. Elsewhere, Arbutus laid off 57% of its workforce and Bicycle Therapeutics shook up its leadership team.

By Ben Fidler • March 28, 2025

Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy

The biotech is slashing a third of its workforce and more than half of its executive team in moves it called “necessary in today’s challenging financial and competitive environment.” 

By Ben Fidler • March 27, 2025

Alcon buys majority stake in IPO-seeking cell therapy startup Aurion

The share acquisition is the latest twist in a dispute between Alcon and fellow Aurion shareholder Deerfield Management over the direction of the company, which filed to go public in January. 

By Kristin Jensen • March 27, 2025

First Prader-Willi drug to reduce hunger approved by FDA

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

By Ben Fidler • Updated March 27, 2025

Bayer gains cancer drug from China’s Puhe; Axsome gets mixed ADHD data

The German firm licensed a PRMT5 inhibitor that’s now in Phase 1 testing. Elsewhere, GSK is testing an intriguing hypothesis and Novo fine tuned its Wegovy cash-pay program.

By BioPharma Dive staff • March 26, 2025

Wave to seek approval of Duchenne drug after mid-stage study data

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

By Kristin Jensen • March 26, 2025

Epicrispr banks $68M to test epigenetic editing on rare muscle disease

The startup is using CRISPR tools to stop errant expression of a gene linked to facioscapulohumeral muscular dystrophy, a disorder on the radars of several drugmakers.

By Gwendolyn Wu • March 26, 2025

Character Biosciences raises $93M with an eye on vision loss drugs

The startup is bringing into Phase 1 testing an experimental treatment it says could be more effective than marketed geographic atrophy medicines.

By Gwendolyn Wu • March 25, 2025

23andMe files for bankruptcy as CEO Anne Wojcicki resigns

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

By Elise Reuter • March 24, 2025