FDA
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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The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.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 • 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 -
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Richard Pazdur, longtime FDA oncology leader, to head agency’s main drug office
The appointment of Pazdur as CDER head comes shortly after the surprise ousting of George Tidmarsh and should quiet many of the “lingering uncertainties” surrounding the FDA, wrote one industry analyst.
By Kristin Jensen • Nov. 12, 2025 -
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FDA to remove safety warnings on hormonal menopause therapy
The decision, issued without the input of an official advisory committee, revises long-held labeling on the drugs cautioning the risk of cancer and heart disease.
By Delilah Alvarado • Nov. 10, 2025 -
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J&J brain drug acquired in $14.6B buyout cleared for broader use
Caplyta, which J&J got in its acquisition of Intra-Cellular Therapies, netted a clearance in major depressive disorder that’s key to achieving the $5 billion in annualized sales the company expects.
By Kristin Jensen • Nov. 6, 2025 -
Permission granted by Biohaven Ltd.
Knocked back by the FDA, Biohaven turns to major cost cuts
The brain drug developer plans to slash R&D expenses by about 60% in the wake of the FDA surprisingly rejecting its rare disease drug Vyglxia.
By Jacob Bell • Nov. 5, 2025 -
Courtesy of UniQure
UniQure dives after FDA’s ‘very surprising’ reversal on Huntington’s gene therapy
The FDA’s abrupt shift on UniQure’s treatment reflects an agency that, under current leadership, is as unpredictable as it's been in years, some analysts said.
By Jacob Bell • Nov. 3, 2025 -
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Bayer receives FDA approval for non-hormonal menopause therapy
Clearance of Lynkuet provides a new alternative to hormone-based treatment for hot flashes and sets up a market battle with Astellas Pharma’s Veozah.
By Delilah Alvarado • Oct. 27, 2025 -
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FDA clears return of GSK’s once-withdrawn multiple myeloma drug
The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market only two years later.
By Ben Fidler • Oct. 23, 2025 -
Courtesy of HLTH 2025
Top RFK aide lashes out against healthcare industry for profiting off of illness
Calley Means stopped short of accusing hospitals, insurers and drug companies from actively working to keep Americans sick, but said it was an "economic fact" that the companies benefit financially when people are ill.
By Susanna Vogel • Oct. 22, 2025 -
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Trump administration
FDA awards 9 companies a new ‘national priority’ voucher to speed drug reviews
A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine were among the first beneficiaries of a pilot program initiated in June.
By Ben Fidler • Oct. 17, 2025 -
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J&J claims success in study testing earlier Tecvayli use in multiple myeloma
The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.
By Jonathan Gardner • Oct. 16, 2025 -
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Trump administration moves to fire HHS employees amid shutdown
“HHS employees across multiple divisions have received reduction-in-force notices,” an administration spokesperson confirmed. It’s a significant escalation of normal shutdown procedures.
By Rebecca Pifer • Oct. 10, 2025
