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.

Aspen’s fresh Parkinson’s data; Aldeyra tanks following FDA rejection

Aspen Neuroscience presented positive Phase 1/2 data for its stem cell-derived therapy. Elsewhere, Aldeyra lost over half its market value following a rejection from the FDA.

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. 

Pfizer’s Ibrance successor moves forward with new study data

The drug, which one analyst described as a “critical” part of Pfizer’s oncology strategy, represents a possible improvement upon Ibrance and other, similar breast cancer medicines from Eli Lilly and Novartis.

R1 starts up with $78M, aiming for a better kidney drug

The startup believes a pill it licensed from a Chinese biotech company could be more potent, and convenient to take, than existing treatments for a common complication of chronic kidney disease.

Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial

Testing revealed weight loss effects some Wall Street analysts believe compare favorably to Lilly’s orforglipron, which regulators could approve within weeks. 

Sarepta tests new Elevidys safeguards; Sana advances diabetes cell therapy

Sarepta has begun evaluating a regimen meant to lower the risk of liver damage in Elevidys recipients. Elsewhere, Inovio laid off staff and a Bayer kidney drug notched another trial victory.

CytomX surges on positive data for ‘masked’ ADC in colorectal cancer

Company shares spiked more than 60% after the therapy surpassed Wall Street benchmarks in Phase 1 testing against late-line colorectal tumors. 

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.

New FDA guidance could elevate pharma’s biosimilar market

Biologic copycats have had a limited impact on U.S. drug prices so far, but loosening regulatory restrictions could help accelerate their progress. 

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.

Evotec, Vistagen lay off staff; Immutep shares collapse on study failure

Evotec will cut 800 employees in its second layoff round since 2024. Elsewhere, Ultragenyx got a needed win and a twice-rejected cell therapy is getting an audience at the FDA.

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.”

With $100M, Vima pursues an oral drug for movement disorders

Incubated by Atlas Venture, the biotech startup is advancing a daily pill it sees potentially helping people with dystonia or Parkinson's disease regain control of movement.

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.

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.

Lilly unveils $3 billion production expansion in China

The Zepbound developer is joining other drugmakers’ rush into China as it plans to boost its oral solid dosage supply chain to support the launch of its obesity pill orforglipron.

Biogen builds case for Spinraza successor with fresh data

More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis' Zolgensma.

Bimzelx tops Skyrizi in head-to-head psoriatic arthritis trial

UCB said it’s the first time an approved biologic demonstrated superiority over an IL-23 blocker in psoriatic arthritis. Yet analysts aren’t sure how commercially impactful the results will be.

BioNTech founders to step down and helm new mRNA startup

Ugur Sahin and Özlem Türeci, who directed the COVID vaccine maker’s rise to prominence, will helm an as-yet-unnamed company dedicated to mRNA discovery work.

UniQure leads genetic medicine biotech rally after news of Prasad’s exit

Vinay Prasad contributed to an uncertain regulatory climate for gene therapy makers focused on rare conditions. Shares of many developers rose on the chance of a more industry-friendly successor.

Vertex kidney disease drug hits mark in late-stage study

Company shares surged in after-market trading on results for a drug Vertex acquired in a multibillion-dollar deal and sees as having “best-in-class potential” in a competitive field.

Updated March 10, 2026

Bristol Myers claims success in study of another next-gen blood cancer drug

The therapy, mezigdomide, is part of group of medicines the pharma sees as successors to its lucrative multiple myeloma drugs Revlimid and Pomalyst.

CSL breaks ground on $1.5B Illinois immunoglobulin plant expansion

The Kanakee project builds on the company’s efforts to increase its U.S. footprint, where it has already spent more than $3 billion, and will focus on producing plasma-derived therapies.

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.

Updated March 7, 2026