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

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

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

Pfizer drug acquired in Seagen deal disappoints in lung cancer study

The setback dims the outlook for a medicine Pfizer sees as an important contributor going forward, though some analysts are optimistic about the drug’s chances in another trial.

By Delilah Alvarado • 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

Hospitals irate after Eli Lilly follows through on 340B ultimatum

The drugmaker stopped paying 340B discounts to hospitals that didn’t comply with its new paperwork requirements late last week. Hospitals are urging HRSA to step in.

By Rebecca Pifer Parduhn • June 23, 2026

The first 14 days: How specialty programs set patients up for success

As specialty medicines play a growing role in healthcare, the patient journey that follows is equally critical.

June 22, 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

Medicare drug price rule may target under-the-skin Keytruda and Opdivo

For 2029, a federal rule proposes closing a "loophole" that protects medicines transitioning from intravenous administration from price protection.

By Jonathan Gardner • June 15, 2026

Lilly scores early positive data for new JAK drug

Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.

By Jacob Bell • June 15, 2026

J&J looks to widen Imaavy’s use; $300M backs rare disease drug launch

New data suggest Imaavy could be an effective treatment for autoimmune anemia. Elsewhere, Enliven detailed data for a Merck leukemia rival and MBX hyperparathyroidism drug hit its goal.

By BioPharma Dive staff • June 11, 2026

Takeda’s $4B TYK2 drug tops Bristol Myers’ Sotyktu in head-to-head test

The results support Takeda’s long-held belief in zasocitinib’s superiority and could help it gain a commercial advantage over Bristol’s therapy. 

By Jonathan Gardner • June 11, 2026

Sanofi stops immune drug trial in latest research setback

The failure adds to a series of mixed or negative readouts and leaves in doubt the future of a therapy Sanofi has viewed as a potential blockbuster.

By Kristin Jensen • June 10, 2026

GSK boosts cancer pipeline with $11B Nuvalent buyout

The British drugmaker's third acquisition this year gives it two experimental lung cancer drugs under FDA review that it hopes will support a franchise.

By Jonathan Gardner • June 9, 2026

Roche stakes $700M on Nurix’s protein-degrading drug

Potentially worth up to $2.3 billion, the collaboration is a bet that drugs able to eliminate the “BTK” enzyme will prove superior to existing medicines that block its activity.

By Ben Fidler • June 8, 2026

Precision under pressure: Logistic solutions for nuclear medicine scalability

Racing the clock: How precision logistics deliver life-saving nuclear medicine.

June 8, 2026

Generic drugmakers gain key victory in ‘skinny label’ patent case

The Supreme Court ruled that a knockoff version of Amarin’s Vascepa didn’t infringe on patents — a decision with far-reaching implications for the availability of generics.

By Jonathan Gardner • June 5, 2026

Pharma is betting big on PD-1/VEGF bispecifics. But are companies chasing the wrong target?

While many drugmakers are focused on lung cancer, evidence shows the liver may be a better bet.

By Kelly Bilodeau • June 5, 2026

Otsuka showcases kidney drug data; Pfizer cuts an AI deal

Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off generic competitors.

By BioPharma Dive staff • June 4, 2026

Eli Lilly issues data sharing ultimatum to 340B hospitals

Select hospitals have refused to share data to prove they’re not double-dipping drug discounts, Lilly said. Hospitals, which have until Monday to comply, are urging the government to intervene.

By Rebecca Pifer Parduhn • June 2, 2026

At ASCO, Merck makes case for a ‘cornerstone’ cancer drug

Study results accrued so far are giving Merck greater conviction that the therapy, licensed from a China-based biotech, was worth placing into a sprawling Phase 3 program.

By Delilah Alvarado • May 29, 2026

Bristol Myers unveils data for one of its next-gen blood cancer drugs

Called mezigdomide, the drug is one of two protein-degrading medicines Bristol Myers hopes to soon position as successors to its lucrative Revlimid franchise.

By Jonathan Gardner • May 29, 2026

Pfizer, Innovent strike $10B cancer drug deal

Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.

By Ben Fidler • May 29, 2026

GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’

The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.

By Jonathan Gardner • May 28, 2026

CVS obesity drug deal puts Lilly on equal footing with Novo

The agreement includes Lilly’s new pill Foundayo and restores coverage for Zepbound, erasing what had been a commercial edge for rival Novo Nordisk. 

By Kristin Jensen • May 28, 2026

Early data for heart drug affirm Lilly’s billion-dollar bet on Verve

The base editing medicine lowered “bad” cholesterol levels along with a key protein, clearing the way for a Phase 2 study.

By Jonathan Gardner • May 26, 2026