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

FDA lays out new path to speed development of multiple myeloma drugs

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change that could accelerate cell therapies and other new medicines. 

By Jonathan Gardner • Jan. 22, 2026

Valneva to withdraw Chikungunya vaccine from US amid safety woes

The decision comes months after the FDA had suspended the vaccine’s license. One analyst speculated the company might shelve the product altogether. 

By Delilah Alvarado • Jan. 20, 2026

Lilly, chasing Novo, expects second-quarter FDA decision on obesity pill

Speaking at the J.P. Morgan conference, CEO David Ricks said he anticipates a “rapid review” for orforglipron that's currently speeding along “at pace.” 

By Jonathan Gardner • Jan. 14, 2026

5 FDA decisions to watch in the first quarter of 2026

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it rejected two years ago.

By BioPharma Dive staff • Jan. 7, 2026

CDC, following Trump’s orders, weakens US stance on childhood vaccinations

In a drastic decision made outside of its typical review process, the agency declared it would recommend 11 childhood shots going forward, down from 17.

By Delilah Alvarado • Updated Jan. 6, 2026

Moderna, searching for a rebound, to seek approval of mRNA flu shot

The company submitted an application for a seasonal flu vaccine it believes to be a key growth driver in the years ahead. 

By Delilah Alvarado • Jan. 5, 2026

Novo Nordisk’s weight loss pill approved by FDA

The clearance brings an oral form of Novo’s Wegovy to market ahead of Lilly’s rival medication and kicks off the next phase of an escalating battle for control of the obesity drug market. 

By Jonathan Gardner • Dec. 23, 2025

Cytokinetics set to battle Bristol Myers as FDA approves heart drug

The clearance is the first in Cytokinetics’ lengthy history and pits its drug Myqorzo against Bristol Myers’ Camzyos, which is on its way to topping $1 billion in sales this year.

By Ben Fidler • Dec. 21, 2025

Lilly obesity pill, headed for quick FDA review, hits mark in ‘maintenance’ trial

Orforglipron helped keep weight down when used after initial therapy with an injectable, a new treatment strategy that could broaden its use in obesity. 

By Jonathan Gardner • Dec. 18, 2025

FDA clears GSK’s twice-yearly asthma drug

Exdensur is now the first asthma biologic to be approved for twice-yearly dosing, and could potentially change standard of care for those with severe disease.

By Delilah Alvarado • Updated Dec. 17, 2025

Enhertu combo cleared for use in frontline breast cancer

The approval could help Enhertu, which is already a multibillion-dollar seller, supplant a regimen that’s been the standard of care for HER2-positive breast tumors for more than a decade.

By Delilah Alvarado • Dec. 16, 2025

FDA approves first drug in National Priority Voucher program

The agency gave the green light to a U.S. company manufacturing Augmentin XR, an antibiotic first approved more than two decades ago.

By Kristin Jensen • Dec. 10, 2025

12 former FDA chiefs blast Prasad’s move to toughen vaccine standards

In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.

By Jonathan Gardner • Dec. 4, 2025