Lilly, Foghorn part ways; Wave’s FDA-approved plans

The pharma giant cut its partnership after a cancer drug disappointed in testing. Elsewhere, Teva and Samsung Bioepis expanded a partnership and space biotech Varda brought in $251 million.

By Gwendolyn Wu • Oct. 1, 2026

5 FDA decisions to watch in the fourth quarter of 2026

The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK and Gilead.

By BioPharma Dive staff • Oct. 1, 2026

FDA starts review of Roche’s multiple sclerosis pill

The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.

By Delilah Alvarado • Sept. 30, 2026

Kodiak skyrockets on positive study data for 2 eye drugs

The Phase 3 findings suggested Kodiak might have multiple threats to Regeneron’s Eylea and added more than $3 billion to the company’s market value.

By Jonathan Gardner • Sept. 28, 2026

Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.

By Ben Fidler • Sept. 28, 2026

Grail multicancer detection test wins FDA advisers’ backing

Panel members said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings, however.

By Susan Kelly • Sept. 24, 2026

FDA nominee Overton parries vaccine questions at Senate hearing

Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.

By Jonathan Gardner • Sept. 24, 2026

Xenon shares fall following depression trial pause

The occurrence of “neuropsychiatric” adverse events in testing fueled investor doubts about a drug the FDA is already reviewing for a form of epilepsy.

By Jonathan Gardner • Sept. 18, 2026

FDA launches pilot program to speed up early US drug research

First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring medicines into human testing. 

By Gwendolyn Wu • Sept. 15, 2026

Scholar Rock SMA drug approved by FDA

Projected by some analysts as a future blockbuster, Isembyld is the first “muscle-targeted” treatment for the disease and, in clinical testing, helped improve motor function in people on standard therapies. 

By Ben Fidler • Sept. 14, 2026

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