BioPharma Dive

The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.

The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail without requiring in-person visits.

Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted immune drug.

A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.

The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.

One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.

Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”

Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.

A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.

Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.

Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.

Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.

After withdrawing its initial filing last year, the immune drugmaker rebounded and added to a recent run of sizable new biotech stock offerings — while boosting its haul even higher through a concurrent private deal.

Even though Elevidys beat Wall Street expectations, analysts expect investor focus to shift toward Sarepta's early-stage RNA drugs.

The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.

While the company claimed a victory, analysts said data from a Phase 1/2 study fell short of expectations. Entrada shares subsequently tumbled more than 50%.

Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.

Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020. 

In its latest earnings report, the Danish drugmaker said sales and profit should shrink less than the company originally anticipated thanks to strong prescription numbers for its new obesity pill.

Avalo reported study success in what’s proven to be a tough-to-treat skin disease. Elsewhere, BioNTech announced plans to close multiple plants and Madrigal picked up an RNA-based drug for MASH.