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STAT806 Endpoints605 BioPharma Dive231 onclive165 Fierce Biotech74 BioSpace71 raps32 fda press20

therapy area

all Oncology81 Cardiology27 Psychiatry & CNS21 Vaccines17 Immunology17 Rare Disease12 Hepatology

STAT+: Pharma’s drug spending deflection
Job lock, surging prescription drug costs, No Surprises Act update, and more from STAT's Health Care Inc.
STAT · 1d agoRegulatoryNeutral↗ source
MapLight dives despite positive data for schizophrenia drug
Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.
BioPharma Dive · 1d agoRegulatoryNeutral↗ source

page 3 of 54

globenewswire health20

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Infectious Disease4

Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO

Most recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy E…

BioPharma Dive · 1d agoRegulatoryNeutral↗ source

STAT+: Sarepta names Michael Severino, former Tessera CEO, as new chief executive

The beleaguered Sarepta Therapeutics named Michael Severino, who previously led Tessera Therapeutics, as its new CEO.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more

An FDA panel recommended that compounding pharmacies be allowed to make two more peptides, a step toward RFK Jr.'s goal to make them more available

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug

Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.

STAT · 1d agoRegulatoryNeutral↗ source

A trend that isn’t fading, ultra-processed baby foods

An FDA advisory panel serves some peptide wins, a measles record, and more health news from Morning Rounds

STAT · 1d agoRegulatoryNeutral↗ source

[Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services

This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.

BioPharma Dive · 1d agoRegulatoryNeutral↗ source

[Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus

This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.

BioPharma Dive · 1d agoRegulatoryNeutral↗ source

From confidence to capital: Positioning biotech for the next growth cycle

How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.

BioPharma Dive · 2d agoRegulatoryNeutral↗ source

Opinion: How midwives like me can help fight medical misinformation

“I have come to believe that changing a mind is rarely the point. Planting a seed is,” writes nurse-midwife Mara Evans.

STAT · 2d agoRegulatoryNeutral↗ source

STAT+: As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities

Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…

STAT · 2d agoRegulatoryNeutral↗ source

Opinion: E-bikes, e-scooters are a burgeoning pediatric public health emergency

“Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.

STAT · 2d agoRegulatoryNeutral↗ source

Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA

The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…

raps · 2d agoRegulatoryNeutral↗ source

‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug

A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.

Fierce Biotech · 1d agoNeutral↗ source

Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears

Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.

Fierce Biotech · 1d agoNeutral↗ source

MapLight shares sink on mixed phase 2 schizophrenia readout

MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.

Fierce Biotech · 2d agoNeutral↗ source

Legend Biotech CEO abruptly steps down without permanent replacement

In a sudden leadership shift, Legend Biotech announced that its CEO, Ying Huang, Ph.D., resigned on Friday, with no permanent replacement yet named.

Fierce Biotech · 2d agoNeutral↗ source

FDA panel backs compounding of epitalon, rejects emideltide in narrow vote

The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…

STAT · 4d agoRegulatoryNeutral↗ source

U.S. measles cases in 2026 already exceed total from record-breaking 2025 year

The CDC reports 2,318 measles cases in the United States so far in 2026, surpassing the 2,289 cases recorded for the entire year of 2025. The increase makes 2026 the worst measles year since 1991,…

STAT · 4d agoNeutral↗ source

Rigel Pharmaceuticals appoints Alison Hannah as executive vice president and chief medical officer

Rigel Pharmaceuticals announced that it has hired Alison Hannah to serve as executive vice president and chief medical officer. Hannah joins Rigel after holding the same senior medical leadership…

STAT · 4d agoPositive↗ source

Former FDA food safety chief warns nutrition push may overlook cyclospora outbreak risks

Susan Mayne, who led the FDA’s Center for Food Safety and Applied Nutrition from 2015 to 2023, argues that nutrition and food safety cannot be treated separately. She says the two are linked and bo…

STAT · 4d agoNeutral↗ source

Amgen sheds around 40 staffers amid continuing struggles

Amgen has laid off around 40 employees as part of “organizational changes” meant to better align operations with the company’s strategic objectives, Fierce has learned.

Fierce Biotech · 4d ago↗ source

Sanofi halts development of troubled immune drug in eczema

The decision to no longer seek approval of amlitelimab is the latest setback for a treatment once hailed as a future blockbuster. One analyst expects Sanofi to now pursue “strategic action” to boos…

BioPharma Dive · 4d ago↗ source

STAT+: Fatal gene-editing trial in China raises ethics and oversight questions

Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout

STAT · 4d ago↗ source