FDA
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Q&APoliticization 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 -
Courtesy of Intellia Therapeutics
Gene editingFDA 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 -
Permission granted by Sanofi
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 -
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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 -
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VaccinesValneva 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 -
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Obesity drugsLilly, 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 -
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Trump administration
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 -
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VaccinesCDC, 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 -
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VaccinesModerna, 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 -
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Obesity drugsNovo 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 -
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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 -
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Obesity drugsLilly 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 -
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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 -
Permission granted by Daiichi Sankyo
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 -
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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 -
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Vaccines12 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 -
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Tracey Beth Høeg, top Makary deputy, named head of FDA drug office
Høeg, a COVID-19 vaccine critic who’s been serving as a special assistant to the commissioner, will be the fifth person this year to run CDER amid heightening scrutiny of the agency.
By Kristin Jensen • Dec. 4, 2025 -
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Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
By Ben Fidler • Dec. 2, 2025 -
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FDA details plan to scale back animal tests for some antibody drugs
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
By Jonathan Gardner • Dec. 2, 2025 -
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Otsuka gains approval for first-of-its-kind treatment against rare kidney disease
In a rapidly heating market, Otsuka is the first to secure FDA clearance for an "anti-APRIL" therapy targeting IgA nephropathy.
By Delilah Alvarado • Nov. 26, 2025 -
Permission granted by Novartis
Novartis wins approval to use SMA gene therapy in older patients
Itvisma, an intrathecal version of Zolgensma, can be used in children, teens and adults to stabilize or improve motor function.
By Jonathan Gardner • Nov. 25, 2025 -
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FDA probes effects of Takeda rare disease drug after patient death
The agency is evaluating whether further regulatory action is warranted after receiving reports of neutralizing antibodies.
By Kristin Jensen • Nov. 24, 2025 -
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UnitedHealth adds former FDA commissioner Scott Gottlieb to board
The company declined to comment on Gottlieb’s appointment, which comes as it works to improve its relationship with federal regulators.
By Rebecca Pifer Parduhn • Nov. 19, 2025 -
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RNAi biotech Arrowhead wins first FDA approval
The clearance of Redemplo for a rare genetic disorder marks Arrowhead’s transition, after two decades, into a commercial-stage company and sets up a turf war with Ionis Pharmaceuticals.
By Delilah Alvarado • Updated Nov. 18, 2025 -
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Gene editingFDA unveils new regulatory roadmap for bespoke drug therapies
The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments custom-made for individuals with rare and serious diseases.
By Ben Fidler • Updated Nov. 13, 2025
