Akeso claims another PD-1/VEGF win; FDA requests more data from Novavax

An ivonescimab-chemotherapy combination succeeded in a study in China. Elsewhere, the FDA asked Novavax for more COVID vaccine data and Regeneron boosted its manufacturing capabilities.

By BioPharma Dive staff • April 22, 2025

RFK Jr. is remaking HHS. Track the changes here.

Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.

By BioPharma Dive staff • Updated Aug. 28, 2025

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Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

Former Neumora CEO to lead Galapagos spinout

Henry Gosebruch is now chief executive of the spinout, which has roughly $2.5 billion and plans to use dealmaking to build a research pipeline targeting cancer, viruses and the immune system.

By Jacob Bell • April 22, 2025

An investment fund sets out to free biotech’s ‘trapped capital’

Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” biotech companies that have suffered significant setbacks.  

By Gwendolyn Wu • April 18, 2025

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

By Ben Fidler • April 18, 2025

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, RNA editing startup Airna tapped a former Sarepta executive to oversee its pipeline.

By BioPharma Dive staff • April 18, 2025

Bluebird says Ayrmid missed deadline for rival takeover bid

The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about $29 million upfront.

By Gwendolyn Wu • April 16, 2025

Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents

After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sarepta will start testing a new gene therapy for limb-girdle muscular dystrophy.

By BioPharma Dive staff • April 16, 2025

Startup Glycomine raises $115M to push rare disease drug deeper into testing

The biotech is developing an experimental drug for the most common of a family of disorders all caused by errors in glycosylation.

By Gwendolyn Wu • April 16, 2025

Third Harmonic outlines plans for dissolution

The Atlas-backed company plans to liquidate its assets, including an experimental drug for chronic spontaneous urticaria it pursued after halting work on a different immune drug in 2022.

By Gwendolyn Wu • April 14, 2025

The critical role of evidence-based databases in pharmacogenomics: Ensuring accuracy, consistency and relevance

Discover how QIAGEN PGXI transforms pharmacogenomics with faster, more accurate insights!

By QIAGEN Digital Insights • April 14, 2025

Amgen says Imdelltra extended survival; Parker Institute adds new leaders

The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

By BioPharma Dive staff • April 11, 2025

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

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