Bristol Myers wins ‘milestone’ FDA approval of myeloma drug acquired from Celgene

The clearance of Zenbexus is the first for a group of protein-degrading “CELMoD” medicines that could help Bristol Myers rejuvenate a key drug franchise.

By Jonathan Gardner • Aug. 14, 2026

Trump signs order seeking to upend childhood vaccine schedule

The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the immunization schedule.

By Delilah Alvarado • Aug. 11, 2026

Replimune rebounds to win FDA approval of melanoma drug

The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.

By Jonathan Gardner • Aug. 6, 2026

Takeda approval ushers in new wave of sleep drugs

An FDA nod mostly clears the way for Orzeyful to enter, by Wall Street estimates, a multibillion-dollar market for drugs that boost “orexin” proteins.

By Jacob Bell • Aug. 6, 2026

Erica Schwartz confirmed as next CDC director

Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.’s tumultuous tenure as HHS chief. 

By Kristin Jensen • Aug. 6, 2026

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

5 FDA decisions to watch in the third quarter of 2026

A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.

By BioPharma Dive staff • July 1, 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