FDA places partial hold on Biohaven’s epilepsy drug

Announced mere weeks after Biohaven sold off rights to the therapy, opakalim, the halt affects a study some analysts believe is necessary to support a potential approval.

By Delilah Alvarado • Sept. 10, 2026

FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders

After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said. 

By Kristin Jensen • Sept. 9, 2026

Trailing rivals, AbbVie scores win with dual-acting myeloma drug

The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.

By Jonathan Gardner • Sept. 4, 2026

FDA OKs Takeda, Protagonist drug for rare blood cancer

The clearance and broader-than-expected label for Mimrylo open up a yearly revenue opportunity for Takeda that some analysts expect to reach $2 billion or more. 

By Delilah Alvarado • Aug. 31, 2026

FDA green lights Priovant drug for rare skin disease

Lisraya’s clearance marks the first approval of a drug the Roivant subsidiary licensed from Pfizer and has since positioned against multiple rare inflammatory conditions.

By Gwendolyn Wu • Updated Aug. 28, 2026

New Jazz cancer drug approval could drive blockbuster sales

Ziihera can now be used as an initial treatment for all HER2-positive gastroesophageal adenocarcinomas, dramatically expanding the drug’s market potential.

By Jonathan Gardner • Aug. 25, 2026

Regeneron to challenge Ipsen as FDA clears bone disease drug

Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.

By Jonathan Gardner • Aug. 20, 2026

Trump nominates policy aide Overton to lead FDA

Heidi Overton, a medical doctor and veteran of the America First think tank, currently serves as deputy director of the White House Domestic Policy Council.

By Kristin Jensen • Updated Aug. 19, 2026

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