FDA approves Moderna’s mRNA flu vaccine

The clearance paves the way for the first preventive flu shot based on mRNA technology and completes a dramatic regulatory turnaround.

By Delilah Alvarado • Aug. 6, 2026

Replimune melanoma drug wins support of FDA panel

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

By Jonathan Gardner • July 30, 2026

Capricor Duchenne cell therapy voted down by FDA panel

At a contentious meeting with possible implications for other rare disease drugmakers, outside experts ultimately determined that Capricor didn't prove deramiocel's benefits in Duchenne-related cardiomyopathy.

By Ben Fidler • July 29, 2026

The FDA was all in on AI. Will that change?

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

By Kelly Bilodeau • July 28, 2026

FDA panel endorses broader use of certain peptides

In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supporting their benefits and safety.

By Ben Fidler • Updated July 26, 2026

Lilly, with new data, to seek FDA approval of obesity drug retatrutide

The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.

By Kristin Jensen • July 23, 2026

GSK lung cancer drug gets speedy approval following $10.6B deal

The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.

By Ben Fidler • July 22, 2026

Merck wins first approval of a PCSK9 cholesterol pill

The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.  

By Ben Fidler • Updated July 16, 2026

Celcuity gains FDA approval for closely watched breast cancer drug

Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.

By Delilah Alvarado • Updated July 15, 2026

HHS plan to speed drug research won’t remove ‘self-inflicted’ delays

U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?

By Kelly Bilodeau • July 9, 2026

Vera Therapeutics wins FDA nod for closely watched kidney disease drug

The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year. 

By Delilah Alvarado • July 7, 2026

Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program

The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.

By BioPharma Dive staff • June 30, 2026

Viridian may have edge over Amgen in eye drug showdown, analysts argue

The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.

By Delilah Alvarado • June 30, 2026

Top FDA gene and cell therapy regulator to step down

Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.

By Jonathan Gardner • June 30, 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

Ionis, with new FDA nod, hits a ‘commercial inflection point’

Historically seen as a "platform monetization story," according to one analyst, Ionis now has a potential multibillion-dollar medicine in Tryngolza, which secured expanded approval Wednesday.

By Delilah Alvarado • June 24, 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

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.

By Jonathan Gardner • June 22, 2026

Moderna flu vaccine wins unanimous support from FDA panel

The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.

By Delilah Alvarado • June 18, 2026

UniQure to file gene therapy for approval, reflecting major shifts at FDA

The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases. 

By Jacob Bell • June 17, 2026

FDA staff scrutinizes evidence supporting Moderna’s flu vaccine

Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year. 

By Delilah Alvarado • June 16, 2026

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.

By Jacob Bell • May 29, 2026

Can a chaotic FDA still deliver on faster drug development?

As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.

By Kelly Bilodeau • 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

FDA delays decision on AstraZeneca breast cancer pill

The review extension comes weeks after an advisory panel found the evidence supporting the drug, camizestrant, inconclusive in what would be a new kind of treatment setting.

By Delilah Alvarado • May 27, 2026