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
    • 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 - Tuesday, May 26, 2026
Breaking News: Ongoing coverage of the Ebola outbreakBreaking News: Ongoing coverage of the Ebola outbreak
Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
BioWorld, Regulatory RSS Feed RSS

Architectural pillars

US Supreme Court says no to Takeda class action challenge

March 23, 2026
By Mari Serebrov
No Comments
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
Read More
Boston Scientific Cryoablation System

NICE issues guidance to improve kidney cancer care

March 23, 2026
By Shani Alexander
No Comments
With incidence of kidney cancer rising in the U.K., the National Institute for Health and Care Excellence (NICE) published its first comprehensive guidelines for diagnosing and treating the disease.
Read More
FDA approved metal stamp
Biopharma approvals February 2026

US FDA clears four NMEs, including those for dermatitis, achondroplasia

March 20, 2026
By Amanda Lanier
No Comments
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when approvals reached 12 in January and 16 in February (28 total), early 2026 activity is consistent with historical ranges.
Read More
NIH Director Jay Bhattacharya

US lawmakers to Bhattacharya: Explain your answers

March 20, 2026
By Mari Serebrov
No Comments
NIH Director Jay Bhattacharya is being fact-checked on his off-the cuff responses at a Senate Health, Education, Labor and Pensions Committee hearing in February. The fact-checkers are nine Democratic lawmakers from Massachusetts, only one of whom (Sen. Ed Markey) is on the committee and attended the hearing. In fact, seven of those signing the March 17 letter that questioned Bhattacharya’s veracity aren’t senators. They serve in the House.
Read More
Light bulb shines next to extinguished ones

Australia’s R&D reset puts biotech translation in focus

March 20, 2026
By Tamra Sami
No Comments
Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.
Read More
Minimed Flex system

Minimed secures FDA nod for next-gen insulin pump

March 19, 2026
By Shani Alexander
No Comments
Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
Read More
Red wooden approved stamp

GSK’s IBAT inhibitor wins US FDA nod for cholestatic pruritus

March 19, 2026
By Karen Carey
No Comments
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.
Read More
Lab mouse and test tubes

FDA, NIH mark milestones toward reducing animal testing

March 19, 2026
By Mari Serebrov
No Comments
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.
Read More
Legal scales and clipboard

340B provider finds new way into court over Rx price disputes

March 18, 2026
By Mari Serebrov
No Comments
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.
Read More
Icotyde

Icotyde’s in; wave of switchers to oral psoriasis Protagonist?

March 18, 2026
By Randy Osborne
No Comments
Awaiting the potential U.S. FDA approval of a second product this year, Protagonist Therapeutics Inc. with partner Johnson & Johnson won the go-ahead for oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, to treat moderate to severe plaque psoriasis in adults and pediatric patients 12 and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy.
Read More
Previous 1 2 … 8 9 10 11 12 13 14 15 16 … 457 458 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 26, 2026.
  • Brain and DNA

    Sangamo presents primate data for prion suppressor ST-506

    BioWorld Science
    Sangamo Therapeutics Inc. discussed gene regulation approaches for neurodegenerative diseases when presenting findings on their clinical candidate ST-506 for the...
  • TREM2 agonists detailed in Pfizer patent

    BioWorld Science
    Pfizer Inc. has reported new triggering receptor expressed on myeloid cells 2 (TREM2) agonists potentially useful for the treatment of neurodegeneration.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 26, 2026
  • Multiple myeloma illustration

    Dual-targeting, rapamycin-enhanced CAR T for multiple myeloma

    BioWorld Science
    Umoja Biopharma Inc. performed preclinical studies to evaluate the antitumor activity of UB-VV500, an off-the-shell lentiviral vector CAR T-cell product. It is...
  • 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