FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.

By BioPharma Dive staff • Sept. 5, 2025

Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug

Led by the former CEO of Hi-Bio and backed by notable investors, the startup licensed from Hengrui a drug it claims is superior to Bristol Myers' Camzyos as well as other, similar medicines.

By Ben Fidler • Sept. 5, 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

Atlas Venture reels in $400M to grow its biotech startups

The venture firm has closed its third "Opportunity Fund,” which complements its early-stage work by supporting startups it's already backed.

By Gwendolyn Wu • Sept. 4, 2025

A drug discovery startup banks $150M for immune and obesity drugs

Enveda Biosciences has raised $300 million over the last year to make drugs to treat atopic dermatitis, asthma and more.

By Gwendolyn Wu • Sept. 4, 2025

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

CEO Vlad Coric said the company has a patient hub, payer managers and a small sales force set up to ensure a successful launch of Vyglxia, a brain medicine that could be approved this year.

By Jacob Bell • Updated Sept. 4, 2025

Secretive startup Treeline unveils first clinical candidates, $200M in new funding

The biotech started by Loxo founder Josh Bilenker and former Novartis executive Jeff Engelman has advanced three cancer drugs to Phase 1 trials.

By Ned Pagliarulo • Sept. 3, 2025

Wave shares sink on new study results for RNA editing drug

Updated findings from Wave’s pioneering trial continued to show its RNA editing therapy is working as intended, but wasn’t as effective in testing as investors had hoped.  

By Ben Fidler • Sept. 3, 2025

Novartis licenses RNA drugs in deal with China-based Argo

The alliance, which could be worth more than $5 billion, is one of a handful of deals Novartis has struck with China-based biotechs in recent years. 

By Kristin Jensen • Sept. 3, 2025

Amgen to invest $600M in new US center; Sanofi drug for ITP approved

The new "science and innovation center" will be built at Amgen's headquarters in Thousand Oaks, California. Elsewhere, Wayrilz became the first BTK blocker cleared for immune thrombocytopenia.

By BioPharma Dive staff • Sept. 2, 2025

Startup Corsera Health aims to bring preventive heart medicine to the masses

Co-founded by RNA interference pioneer John Maraganore and former Medicines Company head Clive Meanwell, Corsera Health is developing diagnostic tools and medicines for heart health.

By Gwendolyn Wu • Sept. 2, 2025

Novo strikes RNA drug deal with startup Replicate

The agreement provides research funding for Replicate and up to $550M in payments to develop medicines for diseases including obesity and diabetes.

By Kristin Jensen • Aug. 28, 2025

Amylyx drug comes up short; Sanofi names new CMO

AMX0035 missed the goals of a study in progressive supranuclear palsy. Elsewhere, Novartis and BioArctic struck a deal, and Genentech started building its first East Coast factory.

By BioPharma Dive staff • Aug. 27, 2025

Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T

The St. Louis-based biotech hopes to submit an application for its leukemia and lymphoma therapy in 2027, if all goes well in an ongoing trial. 

By Kristin Jensen • Aug. 27, 2025

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.

By Alexandra Pecci • Aug. 26, 2025

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.

By BioPharma Dive staff • Aug. 22, 2025

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.

By Gwendolyn Wu • Updated Aug. 21, 2025

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.

By Jonathan Gardner • Aug. 21, 2025

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. 

By Kristin Jensen • Aug. 21, 2025

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.

By Ben Fidler • Aug. 20, 2025

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. 

By Jonathan Gardner • Aug. 19, 2025

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.”

By Delilah Alvarado • Aug. 19, 2025

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.

By BioPharma Dive staff • Aug. 19, 2025

Omega’s Otello Stampacchia on the ‘reset’ changing biotech for the better

Tough times in the industry are forcing changes in investment and governance that should result in a healthier sector, the Omega Funds founder said.

By Gwendolyn Wu • Aug. 19, 2025

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.

By Jonathan Gardner • Aug. 18, 2025

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.

By Delilah Alvarado • Aug. 18, 2025