UniQure falls further on Makary comments

Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.

By Jacob Bell • Feb. 27, 2026

Moderna’s combination flu, COVID shot wins over European drug regulators

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for Moderna’s vaccine in the U.S. 

By Delilah Alvarado • Feb. 27, 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

Generate caps a strong month for biotech IPOs with $400M offering

The AI drug discovery specialist is the fifth biotechnology company to go public in February and priced the sector’s largest new stock offering in nearly three years.

By Gwendolyn Wu • Feb. 26, 2026

Boehringer drug approved in 44 days; BioMarin shelves Roctavian

Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval. Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid dividends.

By BioPharma Dive staff • Feb. 26, 2026

Sarepta CEO Doug Ingram to retire, with company at a crossroads

Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling Elevidys sales and emerging competitors to its core business. 

By Ben Fidler • Feb. 26, 2026

Alkermes’ Richard Pops to step down after three-decade run as CEO

One of biotech’s longest-tenured leaders, Pops steered Alkermes through several reinventions, the latest of which has made it a frontrunner in developing a new narcolepsy drug.

By Jonathan Gardner • Feb. 25, 2026

With Vivtex deal, Novo gains a chance at better oral obesity drugs

The potentially $2.1 billion collaboration gives Novo access to technologies that are meant to help optimize the delivery of oral biologic medicines. 

By Gwendolyn Wu • Feb. 25, 2026

BreezeBio banks $60M to make more precise genetic medicines

The company has shed its former “GenEdit” name and strategy in favor of a plan to develop its own medicines, starting with a potential tolerance-inducing treatment for Type 1 diabetes.

By Gwendolyn Wu • Feb. 25, 2026

Vir climbs on Astellas deal, study results for ‘masked’ T cell engager

According to one analyst, the alliance and early data “validate” the oncology work of Vir, which was once purely an infectious disease specialist before changing course.

By Delilah Alvarado • Feb. 24, 2026

Novo to cut GLP-1 drug prices; Palvella soars on study data

Wegovy and Ozempic’s list prices will be reduced by as much as 50% effective next year. Elsewhere, Palvella’s market value surged past $1 billion while Pfizer nabbed rights to another obesity drug.

By BioPharma Dive staff • Feb. 24, 2026

Slate starts up with $130M and a headache drug from China

The biotech is developing a drug aimed at a protein called PACAP, which has emerged as a potentially new way to prevent the onset of migraines.

By Gwendolyn Wu • Feb. 24, 2026

Madrigal sees a stock sell-off; ex-Novartis exec heads to Daiichi

Madrigal shares fell 11% despite again topping consensus sales numbers. Elsewhere, Daiichi Sankyo named a new research chief and J&J halted recruitment in an Alzheimer’s trial. 

By Ben Fidler • Feb. 20, 2026

AI is slashing jobs across industries. Will pharma be next?

Despite a wave of AI-fueled layoffs, the pharma and biotech industries could be spared from massive cutbacks for now.

By Alexandra Pecci • Feb. 20, 2026

Altesa, run by former Trump official, raises $75M for well-traveled lung drug

Led by Brett Giroir and GSK’s ex-chief medical officer, Altesa is advancing a medicine that’s changed hands multiple times and once failed a study in asthma.  

By Gwendolyn Wu • Updated Feb. 20, 2026

FDA accepts BMS protein degrader for review; Disc rare disease drug rejected

Cytokinetics’ heart disease drug secured European approval. Elsewhere, Teva and Sanofi reported longer-term data from an experimental therapy targeting ulcerative colitis and Crohn’s disease.

By BioPharma Dive staff • Feb. 18, 2026

An Alzheimer’s startup emerges with $175M in venture backing

Backed by Wellington, Sanofi Ventures and a division of J.P. Morgan, Korsana Therapeutics is studying a treatment originally developed by hub-and-spoke biotech Paragon Therapeutics.

By Gwendolyn Wu • Feb. 18, 2026

Psychedelics stocks rise as Compass’ psilocybin drug heads to FDA

Shares of at least four other developers were up by mid-single digits to low-double digits at certain points on Tuesday.

By Jacob Bell • Feb. 18, 2026

FDA reverses course on Moderna’s flu vaccine

In response to a query from BioPharma Dive, an HHS spokesperson said the FDA will “maintain its high standards during drug review and potential licensure stages.”

By Delilah Alvarado • Updated Feb. 19, 2026

Compass, with Phase 3 hits, ready to take psilocybin to the FDA

The company plans to meet with the FDA to discuss a rolling approval application for “COMP360,” a synthetic form of psilocybin that could become the first “classic” psychedelic cleared for the U.S. market.

By Jacob Bell • Feb. 17, 2026

Ocular claims a win with eye drug data even as shares sink

Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, analysts said.

By Kristin Jensen • Feb. 17, 2026

Lyell starts first-of-its-kind CAR-T trial; New coalition aims to boost European biotechs

Lyell’s trial will test its experimental cancer cell therapy directly against marketed counterparts. Elsewhere, Biogen swapped board chairs and venture firms are joining up at a “pivotal time” for Europe.

By BioPharma Dive staff • Feb. 13, 2026

Ultragenyx cuts jobs as it seeks path to profit in 2027

Another FDA knockback for a gene therapy has investors and analysts redrawing expectations for the rare disease drug developer.

By Jonathan Gardner • Feb. 13, 2026

Moderna shares jump as company affirms growth outlook

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

By Delilah Alvarado • Feb. 13, 2026

Earnings roundup: Neurocrine slumps, Alnylam battles skeptics and Ascendis eyes a competitor

Neurocrine and Alnylam each face investor questions about the growth potential of key franchises. Ascendis, meanwhile, saw an upbeat sales report overshadowed by the progress of an emerging rival. 

By Jacob Bell • Feb. 12, 2026

Seres to lay off staff, pause top program in latest reboot

The microbiome specialist, which for years has struggled to stay afloat, is cutting its staff by 30% and focusing resources on earlier, immunology-focused research.

By Delilah Alvarado • Feb. 12, 2026