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

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

FDA hold puts Aardvark Prader-Willi drug in limbo

The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.

By Jonathan Gardner • May 15, 2026

FDA’s leadership void leaves biotech with renewed ‘uncertainty’

Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.

By Jonathan Gardner • May 13, 2026

FDA chief Marty Makary resigns from agency, ending tumultuous tenure

Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with drugmakers.  

By Ben Fidler • May 12, 2026

UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy

News of the submission, which would be the first for UniQure’s closely watched treatment, comes as the therapy faces an uncertain future in the U.S. 

By Delilah Alvarado • April 30, 2026

RFK Jr. defends HHS tenure, 12% proposed budget cut

Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some raised concerns about proposed budget cuts to the National Institutes of Health.

By Emily Olsen • April 20, 2026

Erica Schwartz, ex-deputy surgeon general, picked to be next CDC director

If confirmed by the Senate, Schwartz could finally fill a void for an agency that’s cycled through multiple leaders over the last year.

By Delilah Alvarado • April 16, 2026