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

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

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

Madrigal turns to RNAi drugs from China to bolster MASH pipeline

The potentially $4.4 billion deal is Madrigal’s second with a China-based biotech and hands the company six preclinical RNA interference medicines for the common liver condition.

By Kristin Jensen • Feb. 11, 2026

Evommune rockets on eczema data; AstraZeneca advances GLP-1 pill

Shares of Evommune nearly doubled on data suggesting it has a potential threat to Dupixent. Elsewhere, a closely watched narcolepsy drug got an FDA decision date and investors scrutinized Upstream’s asthma results.

By BioPharma Dive staff • Feb. 11, 2026

FDA refuses to review Moderna’s mRNA flu vaccine

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.

By Delilah Alvarado • Feb. 11, 2026

Gilead dips as ‘strong’ earnings outweighed by high expectations for new HIV drug

Shares fell as much as 6% in after-hours trading, a decline one analyst guessed may be because Yeztugo’s trajectory isn’t matching investors’ sky-high hopes.

By Jacob Bell • Feb. 10, 2026

Nektar, continuing comeback, says eczema drug’s effects hold up in follow-up study

The results vaulted Nektar’s market value to over $1 billion amid expectations the drug might prove a challenger to widely used medications like Dupixent. 

By Jonathan Gardner • Feb. 10, 2026

Lilly buys ‘in vivo’ CAR-T maker Orna, extending streak of genetic medicine deals

Worth up to $2.4 billion, the acquisition is also the latest in a series of buyouts involving startups with technologies that modify immune cells inside the body. 

By Jonathan Gardner • Feb. 9, 2026

Lilly bets again on China drugs; Roche showcases MS data

Lilly could pay Innovent Biologics up to $9 billion in a new alliance. Elsewhere, Roche tried to assuage investor concerns about its new multiple sclerosis drug and Roivant shares surged.

By BioPharma Dive staff • Feb. 9, 2026

Takeda, Iambic partner in latest pharma AI push

“The winners over the next five years” will be the companies that “fully integrate” artificial intelligence into drug development, said Takeda research chief Andy Plump.

By Jacob Bell • Feb. 9, 2026

Hengrui, Kailera tout positive results for dual-acting obesity pill

Kailera CEO Ron Renaud claimed the weight loss effects and safety profile observed in the study suggest its therapy could eventually become a “differentiated treatment option” compared to other obesity pills.

By Delilah Alvarado • Feb. 9, 2026

Agomab, SpyGlass bank a combined $350M in biotech IPOs

The two offerings capped off the busiest week for new biotech stock issuances in a year.

By Gwendolyn Wu • Feb. 5, 2026

Generate, an AI-driven Flagship startup, pitches an IPO

The biotech, which raised more than $800 million privately on the promise of artificial intelligence-aided drug discovery, is developing a potential competitor to the asthma treatment Tezspire.

By Kristin Jensen • Feb. 5, 2026

Eikon Therapeutics nets a $381M IPO amid burst of biotech offerings

Eikon’s offering ranks as the largest new biotech stock issuance since Acelyin’s $540 million haul nearly three years ago.

By Gwendolyn Wu • Feb. 4, 2026

Earnings roundup: Amgen vs. FDA, Pfizer’s defense and Merck’s $70B-in-sales plan

Amgen is refusing U.S. regulators’ request to withdraw an inflammatory disease drug. Elsewhere, Pfizer battled skepticism on new obesity drug data, and Merck laid out its post-Keytruda future.

By BioPharma Dive staff • Feb. 4, 2026

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

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