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STAT805 Endpoints604 BioPharma Dive231 onclive165 Fierce Biotech74 BioSpace71 raps32 fda press20

therapy area

all Oncology81 Cardiology27 Psychiatry & CNS21 Vaccines17 Immunology17 Rare Disease12 Hepatology

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

page 4 of 56

globenewswire health20

6

Infectious Disease4

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

Denmark’s foundation‑fueled biotech boom redraws the Nordic map

Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.

BioSpace · 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

FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy

The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…

BioSpace · 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 · 1d 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

CLINUVEL to cut up to 20% of staff and move headquarters to New York

CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…

BioSpace · 2d agoLayoffsNegative↗ 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

Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped

Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.

BioSpace · 4d ago↗ source

Scribe reels in nearly $129M in rare early-stage IPO for a gene editing biotech

Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silen…

BioSpace · 4d ago↗ source

Amgen deploys patients to defend troubled Tavneos in FDA hearing request

Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.

BioSpace · 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

STAT+: Pharmalittle: We’re reading about an FDA panel and peptides, a Merck license for an HIV pill, and more

In a win for peptide proponents, an FDA advisory panel recommended compounding pharmacies be allowed to make four of the drugs

STAT · 4d ago↗ source

Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma

Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.

BioPharma Dive · 4d ago↗ source

Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects

A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…

Fierce Biotech · 4d ago↗ source