FDA approves Lilly obesity pill, triggering battle with Novo Nordisk

Foundayo could erase the Wegovy pill’s four-month head start as the two drugmakers clash on a debate of efficacy and convenience.

By Jonathan Gardner • April 1, 2026

A ‘hijacked plane’: CDC, under RFK Jr.’s influence, trades science for dogma

A series of controversial policy changes directed by the HHS secretary have left experts fearful of the future implications for public health. 

By Delilah Alvarado , Shaun Lucas • April 1, 2026

FDA, after turbulent year, leaves drugmakers guessing on its direction

Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator is as unpredictable as it’s ever been.

By Jonathan Gardner , Shaun Lucas • April 1, 2026

Rocket gene therapy cleared by FDA for rare immune disorder

Though the therapy, Kresladi, isn’t seen as a big seller, its clearance is a step forward for a company that’s lost most of its value since 2021 amid several setbacks.  

By Ben Fidler • March 27, 2026

FDA clears Denali drug in ‘clear step’ for rare disease biotechs

The approval of Denali’s Hunter syndrome treatment, Avlayah, comes after a series of drug rejections and delays that had led to criticism of the FDA’s stance on rare disease therapies.

By Kristin Jensen • March 26, 2026

Rhythm obesity drug wins broader use from FDA

Imcivree’s approval in a type of obesity driven by brain injury could unlock an opportunity Wall Street analysts believe to be worth more than $1 billion.

By Ben Fidler • March 20, 2026

Novo uses FDA voucher to win speedy approval of higher-dose Wegovy

The clearance, issued 54 days after an approval submission, gives Novo another chance to claw back market share from Eli Lilly. 

By Ben Fidler • March 19, 2026

Bicycle to lay off 30% of staff, pivot away from Padcev challenger

The company now expects a longer path to approval than anticipated, leading it to deprioritize a therapy billed as a threat to Pfizer’s fast-selling bladder cancer drug. 

By Jonathan Gardner • March 17, 2026

Federal court blocks RFK Jr.’s moves to upend US vaccine policy

The ruling, related to a lawsuit from several major medical organizations, stated that HHS ignored established protocols in altering the childhood immunization schedule and overhauling a key CDC panel.

By Delilah Alvarado • March 17, 2026

With FDA go ahead, a China biotech notches a first in cell therapy testing

The trial clearance for Shanghai-based Unixell is another step forward for the rapidly advancing Chinese biotech ecosystem, which has invested heavily in cell and gene therapy technology.

By Jacob Bell • March 13, 2026

GSK’s RSV vaccine wins broader FDA clearance

The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost uptake of a shot that’s posted flattening sales after an initially strong launch.

By Delilah Alvarado • March 13, 2026

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