Lilly warns GLP-1 knockoffs may be ‘dangerous,’ escalating war with compounders

Lilly asked the FDA to step in after claiming that testing it’s done suggests copycat versions of Zepbound may carry “unknown risks.”

By Jonathan Gardner • March 12, 2026

FDA to unify agency’s ‘fragmented’ safety surveillance system

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.

By Kristin Jensen • March 12, 2026

FDA clears repurposed GSK drug for ultra-rare brain disease instead of autism

Months after promising help for “hundreds of thousands of kids,” the FDA approved the decades-old medicine for a disease documented in less than 50 people.

By Kristin Jensen • March 11, 2026

Vinay Prasad, controversial FDA leader, to again depart agency

Prasad’s planned departure, expected at the end of April, culminates a tumultuous term in which he reworked vaccine guidelines and was criticized for his office’s stance on several rare disease drugs.

By Jonathan Gardner , Ben Fidler • Updated March 7, 2026

FDA issues speedy approval to J&J’s Tecvayli-Darzalex combo

The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.

By Jonathan Gardner • March 6, 2026

PepGen muscular dystrophy drug gets ‘surprise’ hold from FDA

The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.

By Kristin Jensen • March 5, 2026

Pierre Fabre seeks to revive US approval chances for spurned cell therapy

Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has surprised some companies and frustrated investors.

By Jonathan Gardner • March 3, 2026

Ascendis wins FDA approval of dwarfism drug

Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo. 

By Delilah Alvarado • March 2, 2026

UniQure says FDA wants another study of Huntington’s gene therapy

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

By Jacob Bell • March 2, 2026

Roche pill succeeds in another MS study, but approval questions linger

Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared Phase 3 studies in multiple forms of the disease.

By Jonathan Gardner • March 2, 2026

UniQure falls further on Makary comments

Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.

By Jacob Bell • Feb. 27, 2026

FDA fleshes out new roadmap for testing personalized therapies

At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.

By Jacob Bell • Feb. 23, 2026

Novo’s next-gen obesity shot fails to match Lilly drug in head-to-head study

Shares fell by more than 15% on results showing study participants receiving Novo’s CagriSema lost less weight than those who took Lilly’s Zepbound.

By Jonathan Gardner • Feb. 23, 2026

Roche gets FDA decision date on closely watched breast cancer drug

The agency could by late December approve a therapy that Roche sees as potentially becoming a new treatment standard for certain breast tumors. 

By Jonathan Gardner • Feb. 20, 2026

FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

By Kristin Jensen • Feb. 19, 2026

FDA reverses course on Moderna’s flu vaccine

In response to a query from BioPharma Dive, an HHS spokesperson said the FDA will “maintain its high standards during drug review and potential licensure stages.”

By Delilah Alvarado • Updated Feb. 19, 2026

FDA removes box warnings for 6 menopausal therapies

The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women.

By Delilah Alvarado • Feb. 13, 2026

HHS elevates officials into Kennedy’s inner circle in advance of midterms

The HHS secretary has four new senior advisors to help him “move faster and go further” on his Make America Healthy Again agenda.

By Rebecca Pifer Parduhn • Feb. 13, 2026

CDC moves to cut $600M in grants to Democrat-led states

The cut grants, which were viewed by Healthcare Dive, fund a wide swath of areas including workforce initiatives, STI prevention measures, health equity proposals, pediatric clinician training and others in California, Colorado, Illinois and Minnesota.

By Sydney Halleman • Feb. 11, 2026

FDA refuses to review Moderna’s mRNA flu vaccine

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.

By Delilah Alvarado • Feb. 11, 2026

FDA rejects Regenxbio treatment in another blow to gene therapy

The decision comes two weeks after the agency halted testing due to safety concerns and represents the latest regulatory setback for a gene therapy maker.

By Gwendolyn Wu • Feb. 10, 2026

Hims cancels plans to sell compounded GLP-1 pill after FDA backlash

Hims said it “deciding to stop offering access” to the treatment following escalating legal threats — among them a patent infringement suit Novo Nordisk filed against the company on Monday.

By Ben Fidler • Updated Feb. 9, 2026

Politicization runs deeper than ever at FDA, risking long-term impacts

A massive overhaul of staffing and review processes have left the agency appearing heavily driven by the Trump administration’s political agenda, according to an economist and public policy expert.

By Michael Gibney • Jan. 30, 2026

FDA lifts hold on an Intellia CRISPR drug trial

Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in people with transthyretin amyloidosis. One of those tests remains suspended.

By Delilah Alvarado • Jan. 27, 2026

Sanofi to seek approval of touted eczema drug despite mixed results

Fresh data from multiple studies suggest the drug, which Sanofi has billed as a future blockbuster, could be cleared in the U.S. but has murky sales prospects.

By Jonathan Gardner • Jan. 23, 2026