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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

Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
BioSpace · 22h agoRegulatoryNeutral↗ source
Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
BioSpace · 22h agoRegulatoryNeutral↗ source

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globenewswire health20

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Infectious Disease4

After PCOS became PMOS, there’s hope for new awareness among Black and Latina women

Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.

STAT · 1d agoRegulatoryNeutral↗ source

Opinion: STAT+: Dementia finally has a business model

The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD

Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories

One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.

STAT · 1d agoRegulatoryNeutral↗ source

ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions

The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…

STAT · 10h agoNegative↗ source

WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status

The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…

raps · 1d agoRegulatoryNeutral↗ source

J&J proposes $5.5B talc settlement

After more than a decade and three failed bankruptcy attempts, an end to Johnson & Johnson’s talc saga may finally be in sight. The company has proposed a $5.5 billion settlement ...

Endpoints · 15h agoNeutral↗ source

Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3

💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...

Endpoints · 18h agoNeutral↗ source

Alnylam's stock is down 30% despite a booming biotech market. Here's why

Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A is up, IPOs are back with record-breaking force a…

Endpoints · 20h agoNeutral↗ source

Mirae raises $5.4M to turn patient texts into data for doctors

As people increasingly turn to AI chatbots for health questions, one startup wants patients to talk to its chatbot about their symptoms, so their doctors can make better treatment decisions. Mirae,…

Endpoints · 20h agoNeutral↗ source

Claris collects $118M to take eye drop into pivotal testing next year

Claris Bio has a fresh CEO, new board chair and $118 million for two pivotal trials to see if its eye drop can succeed in a blinding disease with no pharmaceutical treatment options. It's a ...

Endpoints · 22h agoNeutral↗ source

Updated: GSK reveals three-year blueprint to cut costs and propel R&D

Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans for a three-year cost-cutting initiative, the launch of at least ...

Endpoints · 22h agoNeutral↗ source

Updated: Altimmune’s GLP-1-based shot cuts drinking in patients with alcoholism

Altimmune said Tuesday that its GLP-1/glucagon agonist reduced drinking in people with moderate-to-severe alcohol use disorder in a mid-stage study. Patients in the Phase 2 RECLAIM trial took a wee…

Endpoints · 23h agoNeutral↗ source

Yarrow to begin trading as it targets Graves; FDA approves Otsuka's ADHD pill

Plus news about Outlook Therapeutics, Gossamer Bio, Apnimed and Entera Bio. 📈 Yarrow closes merger to go public: Yarrow Bioscience is developing an anti-TSHR antibody for Graves’ disease and thyro…

Endpoints · 1d agoApprovalPositive↗ source

Otsuka’s ADHD approval opens up new drug class with $615M opportunity

Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.

BioSpace · 1d agoApprovalPositive↗ source

UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.

BioSpace · 1d agoPositive readoutPositive↗ source

Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom

Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…

BioSpace · 2d agoNeutral↗ source

Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval

Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…

BioSpace · 2d agoPositive readoutPositive↗ source

WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk

The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…

raps · 2d agoRegulatoryNeutral↗ source

EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list

The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…

raps · 2d agoRegulatoryNeutral↗ source

FDA issues three new guidances to expand eligibility criteria for cancer trials

The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…

raps · 2d agoRegulatoryNeutral↗ source

The patent cliff is looming and CDMOs need to be prepared, Fujifilm CEO says

As drugmakers prepare for the looming biopharma patent cliff, 2026 has so far been a year for dealmaking. Now, contract manufacturers need to broaden their services to keep up, Fujifilm Biotechnolo…

Endpoints · 1d agoDealNeutral↗ source

AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure

AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…

BioSpace · 1d agoDealNeutral↗ source