Gilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule

A settlement could extend the exclusivity of the world’s best-selling HIV medicine to 2036. Elsewhere, an AstraZeneca drug acquisition paid more dividends and a Vertex veteran became Stoke’s full-time CEO.

By BioPharma Dive staff • Oct. 6, 2025

Chiesi buys into Arbor gene editing drug for rare kidney disease

The Italian drugmaker will pay as much as $115 million in upfront and near-term payments in a deal that gives it rights to a treatment in early-stage testing for primary hyperoxaluria type 1.

By Gwendolyn Wu • Oct. 6, 2025

Explore the Trendline➔

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

Immune reset: How T cell engagers can change the autoimmune treatment landscape

T cell engagers could redefine autoimmune care around lasting remission and patient experience.

By Jeffrey Jones, Chief Medical Officer, Cullinan Therapeutics • Oct. 6, 2025

FDA clears generic abortion pill; CMS punts ‘combo drug’ guidance

The decision to clear another mifepristone generic sparked political backlash. Elsewhere, investors will pump up to $175 million into Ovid after the company reported early, but encouraging, data for a potential epilepsy drug.

By BioPharma Dive staff • Oct. 3, 2025

Cartography secures $67M in pursuit of ‘differentiated’ cancer drugs

The company is working on T cell engagers and other multifunctional antibodies, led by a prospect it believes might be helpful treating the vast majority of colorectal cancer cases.

By Gwendolyn Wu • Oct. 2, 2025

The top biopharma conferences in 2026

Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies’ research progress. Here’s a list of conferences to watch next year.

By Ben Fidler • Oct. 1, 2025

A new biotech aims to get RNA drugs into the brain

Dublin-based Aerska launched on Wednesday with $21 million in seed funding and a technology designed to shuttle RNA interference medicines past the blood-brain barrier.

By Jacob Bell • Oct. 1, 2025

As shutdown begins, FDA to stop accepting new drug submissions

The funding lapse triggered by the U.S. government shutdown is the latest test for an agency that’s already dealt with significant layoffs and leadership upheaval this year.

By Kristin Jensen • Oct. 1, 2025

FDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech

George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.  

By BioPharma Dive staff • Oct. 1, 2025

Metsera strengthens case for Pfizer buyout with latest study data

In a Phase 2 trial, a drug at the center of the $4.9 billion deal matched the type of weight loss trajectory seen in testing of Eli Lilly’s Zepbound.

By Jonathan Gardner • Sept. 30, 2025

Crystalys debuts with $205M and plans for a better gout drug

The biotech is starting up with partial rights to a drug that’s approved in multiple Asian countries and its executives see as a superior version of the now-withdrawn gout medication Zurampic.

By Gwendolyn Wu • Sept. 30, 2025

Star raises another $125M for its blood disease drug

Star hopes its drug, which is currently in late-stage testing, might prove a more convenient, longer-lasting alternative to standard therapies for Von Willebrand disease.

By Gwendolyn Wu • Sept. 30, 2025

Genmab to acquire closely watched cancer drug in $8B Merus buyout

The deal hands Genmab a drug that showed the potential in earlier testing to extend survival in head and neck cancer when added to Merck’s widely used immunotherapy Keytruda.

By Delilah Alvarado • Sept. 29, 2025

Moonlake shares crash on mixed study results for immune drug

Anticipated late-stage results in the skin disease hidradenitis suppurativa were described by analysts as “disappointing” and “undifferentiated,” erasing more than four-fifths of the company’s market value.

By Ben Fidler • Sept. 29, 2025

Crinetics drug to challenge pharma ‘Goliaths’; FDA, ARPA move to speed gene therapies

Crinetics’ acromegaly treatment will go up against several entrenched medicines. Elsewhere, Bristol Myers moved to sell Sotyktu online at a discount and regulators rejected a new version of Biogen’s Spinraza.

By BioPharma Dive staff • Sept. 26, 2025

UniQure to seek approval of Huntington’s gene therapy after trial win

New study data showed treatment slowed signs of disease progression by 75% after three years, a finding that could have “massive effects on patients’ lives,” an investigator said.

By Jonathan Gardner • Sept. 24, 2025

Pharma’s next generation of antibodies takes a ‘more is better’ approach

A recent report from Back Bay Life Science Advisors shows a surge in testing of, and investment in, multifunctional antibodies that can hit two or more targets at once.

By Kelly Bilodeau • Sept. 24, 2025

Sanofi Ventures banks $625M to back young biotechs, digital health startups

The French pharma’s venture arm will use the funds to back companies working in immunology, neurology, rare diseases and vaccines.

By Gwendolyn Wu • Sept. 24, 2025

Scholar Rock SMA drug rejected by FDA over manufacturing concerns

The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.

By Ben Fidler • Sept. 23, 2025

FDA clears under-the-skin Keytruda; MBX shares double on study data

The clearance of Keytruda QLEX follows similar approvals for Bristol Myers and Roche. Elsewhere, MBX’s parathyroidism drug impressed investors and Roche claimed success in a breast cancer study.

By Ben Fidler • Sept. 23, 2025

Why Xoma, a drug royalty firm, is hunting biotech ‘zombies’

The collapse in value of many biotechs over the past few years has created an opportunity for specialists like Xoma to “do the right thing” for the ecosystem and liquidate them, its executives say.

By Gwendolyn Wu • Sept. 23, 2025

MapLight lines up an IPO in bid to challenge Bristol Myers schizophrenia drug

The company, which is developing a competitor to Cobenfy, aims to become one of rare biotechs to price a large IPO of late.

By Gwendolyn Wu • Sept. 22, 2025

Pfizer buys back into obesity drug chase with $4.9B Metsera deal

The deal ends a short run as a publicly traded company for Metsera, which is being sold for more than double its IPO price amid enthusiasm for its weight loss medicines.

By Jonathan Gardner • Sept. 22, 2025

Arvinas reboots, cuts more staff; Porges joins Lazard

Pfizer and Arvinas plan to out-license their partnered drug vepdegestrant. Elsewhere, Novo shared more data for oral Wegovy and Vertex reached a deal in Italy for coverage of its gene editing medicine Casgevy. 

By BioPharma Dive staff • Sept. 19, 2025

A new biotech venture firm emerges, led by Bob Langer’s son

T.Rx Capital was co-founded by Michael Langer, former Pear Therapeutics CEO Corey McCann and Eli Lilly veteran Kwesi Frimpong-Boateng, and raised just shy of $80 million for its first fund.

By Gwendolyn Wu • Sept. 18, 2025