BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • BCI
    • Ebola outbreak
    • Hantavirus
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, July 9, 2026
Home » Topics » North America » U.S.

U.S.
U.S. RSS Feed RSS

Ulcerative colitis

Spyre’s SPY-001 induces better outcomes in ulcerative colitis

April 13, 2026
By Brian Orelli
No Comments
Spyre Therapeutics Inc. is off to a good start in its goal to create the best combination therapy for inflammatory bowel disease, a group of chronic, relapsing autoimmune conditions of the digestive tract that encompasses Crohn’s disease and ulcerative colitis. The Waltham, Mass.-based company estimates the market for IBD is currently at approximately $25 billion but will jump to around $40 billion in 2030.
Read More
Art concept for hematologic cancer

MRD word heard loud, clear in Allogene LBCL cema-cel phase II

April 13, 2026
By Randy Osborne
No Comments
“Home-run” efficacy and what Cowen analyst Tyler Van Buren called “pristine” safety in the phase II Alpha3 study with CAR T therapy cemacabtagene ansegedleucel (cema-cel) sent shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) skyward to a $4.46 high, up nearly 64%, on April 13. Shares eventually closed at $3.06, up 34 cents.
Read More
3D pancreas illustration

Revolution’s daraxonrasib nails endpoints in pancreatic cancer trial

April 13, 2026
By Jennifer Boggs
No Comments
“Unprecedented,” “remarkable” and “transformative” were just a few of the descriptives tossed out by Wall Street analysts in response to Revolution Medicines Inc.’s phase III readout, showing RAS inhibitor daraxonrasib hit its overall survival and progression-free survival endpoints in previously treated patients with metastatic pancreatic ductal adenocarcinoma, setting up the company for potential regulatory filings this year and triggering another round of M&A speculation.
Read More
Cholesterol plaque in artery

Lipid reading: Street not deaf to ACC data

April 13, 2026
By Randy Osborne
No Comments
Abstracts released ahead of the American College of Cardiology meeting held in late March in New Orleans, along with the start of dosing near the end of January in Novartis AG’s phase IIb trial with siRNA therapy DII-235, also known as BW-20829, perked up the already-lively lipids/heart space.
Read More
Photo of magnifying glass inspecting moles on person's back

Second CRL for Replimune’s RP-1 for melanoma

April 10, 2026
By Jennifer Boggs and Karen Carey
No Comments
Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.
Read More
Brain scans

FDA accepts Telix’s resubmitted NDA for brain imaging agent

April 10, 2026
By Tamra Sami
No Comments
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
Read More
Vial and syringe with blue hues

Kennedy expands ACIP function, membership criteria

April 10, 2026
By Mari Serebrov
No Comments
Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>
Read More
Chalkboard with straight arrow erased, drawing a turning arrow

Changes afoot at Teleflex to right ship

April 10, 2026
By Shani Alexander
No Comments
Teleflex Inc. reported that Stephen Klasko will step down as chair of the board, and said it intends to establish a new Growth and Operating Committee as well as repurchase $1 billion of its shares. The moves come amid pressure from activist investor Irenic Capital Management, which owns a 2% stake and recently urged the company to take a more constructive and responsible approach to evaluating strategic alternatives, after Teleflex declined to engage with potential acquirors despite interest from multiple credible parties.
Read More
Brain scans

FDA accepts Telix’s resubmitted NDA for brain imaging agent

April 10, 2026
By Tamra Sami
No Comments
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
Read More
Cyber security padlock

Stryker expects cyberattack to impact Q1 results

April 10, 2026
By Shani Alexander
No Comments
Stryker Corp. revealed that the cyberattack which occurred last month had a material impact on its operations and will impact its financial results for the first quarter of 2026. However, the company said in an SEC filing that it is now fully operational and does not expect the incident to have a material impact on its 2026 full-year guidance.
Read More
Previous 1 2 … 27 28 29 30 31 32 33 34 35 … 621 622 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 8, 2026.
  • 3D rendering of an antibody drug conjugate

    ‘Target-high but uptake-defective’ state identified in ADC resistance

    BioWorld
    Separate research teams have reported new insights into resistance mechanisms to the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin, Astellas Pharma...
  • Illustration of brain and brain waves, concept of focal seizure

    Hyperexcitability may be joint problem in epilepsy, dementia

    BioWorld
    The majority of epilepsies are developmental disorders that start in childhood. But there is a large minority that starts in late adulthood. And increasingly,...
  • Modius Spero wearable neuromodulation device

    Neurovalens granted FDA approval for PTSD therapy for US veterans

    BioWorld
    Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device,...
  • Myelin sheath and neurons in the brain

    GDE4 blockade promotes remyelination, study finds

    BioWorld Science
    Myelin is crucial for the correct functioning of nerve signaling and its loss is a feature of neurological disorders. The cells responsible for myelination in the...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing