• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Pills, syringes, financial charts

Economics cited as a driver of worsening drug, device shortages

May 17, 2024
By Mark McCarty
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.
Read More
FDA Approved stamp
Biopharma regulatory actions and approvals April 2024

US FDA continues high pace in April with 26 drug approvals

May 17, 2024
By Amanda Lanier
In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
Read More

FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer

May 17, 2024
By Marian (YoonJee) Chu
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
Read More
Imdelltra vials and product packaging

Amgen wins nod for first T-cell engager in small-cell lung cancer

May 17, 2024
By Lee Landenberger
The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval may well lead the drug to blockbuster status while bolstering the company’s cancer portfolio.
Read More
Arcscan

China approves Arcscan’s ultrasound imaging device for myopia

May 17, 2024
By Marian (YoonJee) Chu
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
Read More
FDA website and logo
FDLI Annual Meeting

Recent FDA activity hints at impending commercial speech enforcement

May 17, 2024
By Mark McCarty
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
Read More
U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 16, 2024
By Mari Serebrov
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
Read More

CMS wants more info for Medicaid price stacking rule

May 16, 2024
By Mari Serebrov
The U.S. Centers for Medicare and Medicaid Services (CMS) is rethinking its proposed “stacking rule” for determining best price in the Medicaid program.
Read More

Report leads to suspension of Ecohealth, NIH rebuke

May 16, 2024
By Mari Serebrov
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Read More

Helsinn gives up on Truseltiq accelerated approval in US

May 16, 2024
By Mari Serebrov
Following a cumbersome process, the U.S. FDA is withdrawing its accelerated approval for Truseltiq (infigratinib) as a second-line treatment for patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Read More
Previous 1 2 … 134 135 136 137 138 139 140 141 142 … 1261 1262 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 12, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 10, 2025
  • Enflonsia

    Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

    BioWorld
    With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and...
  • Red blood cells in an artery with cholesterol

    In two phase IIIs, Merck’s PCSK9 inhibitor cuts cholesterol

    BioWorld
    In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe