FDA launches ‘PreCheck’ program; AstraZeneca, Acadia drugs set back

The agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a self-administered lupus drug was turned back and MeiraGTx picked up another gene therapy.

By BioPharma Dive staff • Feb. 3, 2026

GSK walks away from pioneering Wave RNA editing drug

Wave claimed GSK is handing back rights to the frontrunning program not because of questions about its potential, but because Wave is better suited to quickly advance a rare disease therapy.

By Ben Fidler • Updated Feb. 2, 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.

By BioPharma Dive staff

Amgen gives up on its once-prized eczema drug

The decision comes more than a year after disappointing initial Phase 3 results and casts further doubt on a class of autoimmune drugs thought to be challengers to treatments like Dupixent. 

By Jonathan Gardner • Jan. 30, 2026

The biopharma industry outlook on 2026: Optimism and tension

A spike in M&A activity and stock prices have pulled biotech out of a yearslong downturn. But regulatory tumult and fierce competition from China could short-circuit the sector's resurgence.

By Ben Fidler • Jan. 29, 2026

Moderna holds a ‘garage sale’; Roche defends obesity drug data

Moderna licensed out a rare disease drug for what an analyst called a “modest” sum. Elsewhere, Roche executives suggested better forthcoming obesity results and Summit’s PD-1/VEGF blocker got an FDA decision date.

By BioPharma Dive staff • Jan. 29, 2026

Tenpoint wins FDA nod for combination presbyopia eye drop

The biotech also raised $235 million in debt and equity funding to support marketing of the drop, which it claims to be an advance over existing treatments from AbbVie and others.

By Gwendolyn Wu • Jan. 29, 2026

Halozyme buys a biotech startup; Cytokinetics launches heart drug

Halozyme is paying as much as $400 million for a drug delivery specialist that could boost its growth prospects, one analyst wrote. Elsewhere, Boehringer dipped into China for a bispecific drug and a trans-Atlantic VC firm restocked.

By BioPharma Dive staff • Jan. 28, 2026

Regenxbio gene therapy trials suspended by FDA over safety worries

The development of a brain tumor in a study participant led regulators to suspend a Hurler syndrome therapy in early testing and a treatment for Hunter syndrome nearing an FDA decision.

By Kristin Jensen • Jan. 28, 2026

FDA lifts hold on an Intellia CRISPR drug trial

Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in people with transthyretin amyloidosis. One of those tests remains suspended.

By Delilah Alvarado • Jan. 27, 2026

An immune drug developer raises $50M to finance its eczema drug testing

TRex Bio banked a Series B extension to advance its atopic dermatitis program, which is competing in a crowded field.

By Gwendolyn Wu • Jan. 27, 2026

China’s edge in early-stage drugmaking ‘likely to persist,’ Pitchbook says

The ongoing surge in licensing deals for early drug prospects should continue this year and involve more cell and gene therapies, which have had trouble securing funding in the U.S., the firm said in a new report.

By Ben Fidler • Jan. 26, 2026

Biotech investor Cormorant secures $150M for another SPAC deal

Amid a rebound in SPAC activity, the prolific “crossover” investor is aiming for its third blank-check merger since 2022 following deals with Moonlake Immunotherapeutics and BridgeBio Oncology Therapeutics.

By Ben Fidler • Jan. 26, 2026

The formula for biotech success in 2026: Confidence, resilience and funding

Survey of 260+ biotech leaders assesses the biotech climate, trends, opportunities and risks.

By Deepali Suri, President, ICON Biotech • Jan. 26, 2026

Novo climbs higher on ‘strong’ Wegovy pill launch; Terns tweaks leukemia drug deal

Novo shares have surged more than 20% amid oral Wegovy’s fast start. Elsewhere, Terns opened up room for a potential partnership and Corcept solidified its case for an ovarian cancer drug.

By BioPharma Dive staff • Jan. 23, 2026

Investors load Corxel with $287M for a ‘differentiated’ obesity pill

The funding will support a GLP-1 pill Corxel licensed from China-based Vincentage in 2024 and that the company believes to be as effective in spurring weight loss as injectable therapies.

By Gwendolyn Wu • Jan. 22, 2026

FDA lays out new path to speed development of multiple myeloma drugs

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change that could accelerate cell therapies and other new medicines. 

By Jonathan Gardner • Jan. 22, 2026

BioMarin vets form Mendra to ‘modernize’ rare disease drug development

Backed with $82 million and led by two of BioMarin’s former executives, Mendra plans to acquire rare disease assets and use AI to help accelerate their development.

By Kristin Jensen • Jan. 22, 2026

Corvus shares nearly triple on positive data for eczema pill

While early, the results indicate drugs known as ITK inhibitors have the potential to match or surpass the efficacy observed with the injectable biologic Dupixent.

By Jonathan Gardner • Jan. 21, 2026

Moderna cancer vaccine holds up; IO Biotech considers a sale

Long-term data suggest Moderna’s personalized melanoma shot provides “durable tumor control,” one analyst said. Elsewhere, Insilico Medicine partnered with a startup on a popular drug target.

By BioPharma Dive staff • Jan. 21, 2026

Kailera’s Ron Renaud on how a China-linked startup can compete in obesity

In an interview with BioPharma Dive, the veteran biotech CEO said there remains a “significant opportunity” for young companies in a market dominated by Novo Nordisk and Eli Lilly.

By Gwendolyn Wu • Jan. 20, 2026

Wegovy pill off to a fast start; Ex-Emergent CEO sued for insider trading

More than 3,000 prescriptions were written for Novo’s GLP-1 pill in its first week on the market. Elsewhere, Emergent reached a settlement over a trading scandal and Sanofi is reportedly circling an eye drug biotech.

By BioPharma Dive staff • Jan. 16, 2026

On biotech’s biggest stage, renewed excitement gets a stress test

A surge in deals and financings had the industry abuzz heading into this year’s J.P. Morgan Healthcare Conference. But some aren’t sure if the rebound is here to stay.

By Jacob Bell • Jan. 16, 2026

JPM26: Paying cash for obesity drugs, renewed IPO optimism and pharma’s cell therapy view

Drugmaker CEOs see online sales channels as a budding opportunity, while some biotech investors told BioPharma Dive to expect a rebound in new stock offerings. 

By BioPharma Dive staff • Jan. 14, 2026

Caldera starts up with $112.5M and a dual-targeting immune drug from China

The biotech is advancing a bispecific medicine aimed at two popular targets and being billed as a potential therapeutic advance for inflammatory bowel disease.

By Kristin Jensen • Jan. 14, 2026

JPM26: Biotech’s M&A lift, the ‘new’ Biogen and Merck’s $70B target

Venture investors are adopting a more aggressive mindset heading into 2026, while Merck, Moderna and Summit are all approaching crucial trial readouts.

By BioPharma Dive staff • Jan. 13, 2026