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 - Sunday, June 7, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

SEC looks to reforms to Make IPOs Great Again

May 19, 2026
No Comments
In a move aimed at incentivizing companies to go and stay public, the U.S. SEC proposed two rulemakings May 19 as a foundation to the agency’s Make IPOs Great Again agenda.
Read More
China and U.S. flags

Life sciences ‘sweet’ opportunity in US-China talks

May 19, 2026
By Mari Serebrov
No Comments
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
Read More

Supreme Court upholds FCA’s ‘whistle while you work’

May 19, 2026
By Mari Serebrov
No Comments
Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional.
Read More
Three syringes illustration

CDC vaccines panel to be ‘re-established’

May 19, 2026
By Mari Serebrov
No Comments
It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP). After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice in the May 19 Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee.
Read More
Wooden stamp with China flag
Cancer

China’s NMPA clears KAT6 inhibitor SYH-2095 for clinic

May 19, 2026
No Comments
China’s National Medical Products Administration (NMPA) has granted clinical trial clearance to SYH-2095 tablets, a novel lysine acetyltransferase 6 (KAT6) inhibitor codeveloped by CSPC Pharmaceutical Group Ltd. and Hangzhou Innogate Pharma Co. Ltd. for the treatment of advanced malignant tumors. SYH-2095 received IND clearance in the U.S. last month.
Read More
Health care and politics illustration

Sen. Cassidy’s primary loss increases uncertainty

May 18, 2026
By Mari Serebrov
No Comments
On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.
Read More
US flag, gavel, book

US Supreme Court swats down several biopharma IRA challenges

May 18, 2026
By Mari Serebrov
No Comments
It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.
Read More
Blood pressure cuff

New hypertension option as Astrazeneca’s Baxfendy wins FDA nod

May 18, 2026
By Jennifer Boggs
No Comments
Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.
Read More
Computer visualization of a CAR T cell attacking a cancer cell.
Immuno-oncology

MD Anderson gains IND nod for CD94-targeted CAR T therapy

May 18, 2026
No Comments
The University of Texas MD Anderson Cancer Center has received IND clearance from the FDA to initiate a phase I trial of a novel CAR T-cell therapy, JV-394, for patients with relapsed or refractory CD94-positive T/natural killer (NK) cell lymphomas.
Read More
Test tube and pH chart

Validity of Actelion patent hinges on temperature

May 15, 2026
By Mari Serebrov
No Comments
Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation.
Read More
Previous 1 2 3 4 5 6 7 8 9 … 1370 1371 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 5, 2026.
  • Liver disease

    FB-7033 demonstrates efficacy in MASH management

    BioWorld Science
    17-β-Hydroxysteroid dehydrogenase 13 (HSD17B13) and lipid transferase CIDEB are known to contribute to metabolic dysfunction-associated steatohepatitis (MASH)...
  • Illustration of antibody carrying radioactive isotope

    Preclinical results support Actinium’s radioconjugate ATNM‑400 for NSCLC

    BioWorld Science
    At the recent meeting of the Society of Nuclear Medicine and Molecular Imaging, researchers from Actinium Pharmaceuticals Inc. presented preclinical efficacy data...
  • Bial-Portela discovers new OX1 receptor antagonists

    BioWorld Science
    Bial-Portela & Ca SA has patented new orexin OX1 receptor antagonists potentially useful for the treatment of anxiety disorders, depression, eating disorders,...
  • New York University identifies new analogues of mannose-6-phosphate

    BioWorld Science
    New York University has discovered new analogues of mannose-6-phosphate reported to be potentially useful for the treatment of memory impairment,...
  • 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