FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services

Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.

By BioPharma Dive staff • June 26, 2026

At BIO, tension over China biotech deal regulation looms

Biotech investors, executives and analysts worry that blanket bans on deals with Chinese companies could curb domestic entrepreneurs’ ambitions in the sector.

By Gwendolyn Wu • June 26, 2026

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

Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda

Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.

By Jacob Bell • June 26, 2026

On second try, Acadia drug gets nod from European regulators

The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.

By Jonathan Gardner • June 26, 2026

Antares gets $105M from Novartis for new cancer drugs

Adam Friedman, CEO of the Scorpion Therapeutics spinout, said the deal helps both companies accelerate research "faster than either of us could alone."

By Gwendolyn Wu • June 25, 2026

Ionis, with new FDA nod, hits a ‘commercial inflection point’

Historically seen as a "platform monetization story," according to one analyst, Ionis now has a potential multibillion-dollar medicine in Tryngolza, which secured expanded approval Wednesday.

By Delilah Alvarado • June 24, 2026

Investors pour $115M into RQ Bio in search of a preventive flu drug

The startup claims to have a “differentiated” antibody that can provide long-lasting protection against a variety of influenza strains.

By Delilah Alvarado • June 24, 2026

To Wall Street, psychedelics biotechs are more teammates than rivals

Some analysts argue that, even for competitors, a big clinical trial win for Definium Therapeutics helps validate the psychedelic field and “bring it even further into the mainstream.”

By Jacob Bell • June 24, 2026

Sangamo holds a bankruptcy sale; VCs back a China-linked Beam competitor

Eli Lilly and Astellas will be the lead bidders at an auction for Sangamo assets. Elsewhere, an investor syndicate committed $230 million to a gene editing startup and Merck KGaA struck a “build-to-buy” deal.

By Ben Fidler • June 24, 2026

Ollin refuels with $330M to back pivotal tests of Vabysmo challenger

One of the year’s largest venture funding rounds comes just after a head-to-head study showed Ollin’s drug — licensed from a China-based developer — had certain advantages over Roche’s eye treatment.

By Kristin Jensen • June 24, 2026

How Kardigan spun deal leftovers into a $400M IPO

CEO Tassos Gianakakos said having late-stage assets and a team fortified at MyoKardia really resonated with investors. SpaceX's huge public offering didn't hurt either.

By Jacob Bell • June 23, 2026

HHS, responding to China’s rise, moves to fast-track early drug research

A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.

By Jonathan Gardner • June 23, 2026

‘The window’s open’: At BIO, investors take stock of a growing class of biotech IPOs

In interviews as well as a panel at BIO’s annual meeting, investors and life sciences bankers predicted an acceleration in offerings later this year — but only among companies fitting a certain criteria.

By Gwendolyn Wu • June 23, 2026

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.

By Jonathan Gardner • June 22, 2026

Sanofi swaps R&D leaders; Merck’s Prometheus deal pays dividends

Houman Ashrafian is leaving Sanofi to pursue a new opportunity. Elsewhere, one of Merck’s prized immune drugs succeeded in a pivotal study and a psychedelics biotech’s shares surged.

By BioPharma Dive staff • June 22, 2026

Bionyra brings in $165M for next-generation immune drugs

The biotech, co-founded by Sofinnova Partners and a former Sanofi immunology R&D head, is testing new biologics against common immune conditions.

By Gwendolyn Wu • June 22, 2026

Moderna flu vaccine wins unanimous support from FDA panel

The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.

By Delilah Alvarado • June 18, 2026

cAMPfield lands $180M to build gut disease drug

The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.

By Jonathan Gardner • June 18, 2026

Biogen adds more immune drugs in $1B buyout of secretive startup RayThera

The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues. 

By Kristin Jensen • June 18, 2026

Pfizer CFO to step down; Denali sells a regulatory fast-pass

A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid dividends.

By Ben Fidler • June 18, 2026

Kardigan extends biotech’s streak of big IPOs with $400M haul

Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.

By Gwendolyn Wu • June 17, 2026

A new Westlake-backed biotech takes aim at migraines

Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention. 

By Jacob Bell • June 17, 2026

FDA staff scrutinizes evidence supporting Moderna’s flu vaccine

Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year. 

By Delilah Alvarado • June 16, 2026

Edgewise heart drug passes key trial test

Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.

By Jonathan Gardner • June 16, 2026

Neumora depression drug fails; EnGene to cut 50% of staff

Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.

By BioPharma Dive staff • June 16, 2026