FDA: Page 2
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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FDA clears return of GSK’s once-withdrawn multiple myeloma drug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 Parduhn • Oct. 10, 2025 -
Courtesy of Regeneron Pharmaceuticals
Regeneron, needing a turnaround, gains new use for cancer drug
Libtayo’s latest approval for a type of skin cancer should boost future sales, according to one analyst, but doesn’t have the “broad-reaching implications” for Regeneron's Eylea franchise investors had hoped.
By Kristin Jensen • Oct. 9, 2025 -
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Boehringer Ingelheim drug wins FDA OK in tough-to-treat lung disease
The clearance makes Jascayd the first new drug for idiopathic pulmonary fibrosis in over a decade, but some analysts see it as a “modest” advance in care.
By Delilah Alvarado • Oct. 8, 2025 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
Peter Marks, former top FDA vaccine official, joins Eli Lilly
Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.
By Jonathan Gardner • Oct. 7, 2025 -
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Trump administration
As shutdown begins, FDA to stop accepting new drug submissions
The funding lapse triggered by the U.S. government shutdown is the latest test for an agency that’s already dealt with significant layoffs and leadership upheaval this year.
By Kristin Jensen • Oct. 1, 2025 -
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News roundupFDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech
George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.
By BioPharma Dive staff • Oct. 1, 2025 -
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Lilly’s oral SERD gets FDA nod in advanced breast cancer
The clearance of Inluriyo is another development among a group of oral medicines aiming to supplant a widely used, injectable type of hormone therapy.
By Ben Fidler • Sept. 25, 2025 -
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Scholar Rock SMA drug rejected by FDA over manufacturing concerns
The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.
By Ben Fidler • Sept. 23, 2025 -
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FDA clears first Barth syndrome drug amid scrutiny of rare disease stance
After an earlier rejection that drew criticism from some observers, the FDA quickly accepted Stealth BioTherapeutics’ new application and cleared its drug’s use.
By Ben Fidler • Sept. 22, 2025 -
Retrieved from Vinay Prasad on May 08, 2025
Trump administrationPrasad regains role as FDA’s top doctor, scientist
An HHS spokesperson confirmed Prasad's reappointment as chief medical and scientific officer, one month after his surprising return to the agency as CBER director.
By Ned Pagliarulo • Sept. 11, 2025 -
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FDA shares guidance to drugmakers developing non-opioid pain medicines
The agency says it’s open to offering speedy approval pathways for new pain medications that can fight the ongoing opioid addiction crisis.
By Kristin Jensen • Sept. 11, 2025 -
Courtesy of Johnson & Johnson
FDA clears J&J’s drug-device combo for bladder cancer
J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.
By Jonathan Gardner • Sept. 10, 2025 -
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New Summit data clouds approval pathway in lung cancer
A combination of ivonescimab and chemo didn’t extend survival over chemo alone in a global trial, missing a key goal often emphasized by regulators.
By Jonathan Gardner • Sept. 8, 2025 -
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FDA outlines new review pathway for drugs treating ultra-rare diseases
The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect fewer than 1,000 people in the U.S.
By Ned Pagliarulo • Sept. 4, 2025 -
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VaccinesFDA approves updated COVID boosters, but narrows use
While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in younger people to those with underlying health conditions.
By Delilah Alvarado • Updated Aug. 27, 2025
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