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
    • 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, April 23, 2026
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Gilead's Descovy becomes second FDA-approved drug to prevent HIV infection

Oct. 7, 2019
By Michael Fitzhugh
WASHINGTON – Since 2012, Americans at risk of HIV-1 infection from sex have had just a single option for reducing their odds of acquiring it: a daily dose of Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate). Now, about a year before Truvada goes generic, at least some of them have a second option in Gilead's Descovy (emtricitabine and tenofovir alafenamide). On Thursday, the FDA approved Descovy for HIV-1 pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Read More

Arbutus halts hep B study after volunteers develop hepatitis

Oct. 7, 2019
By Lee Landenberger
Rough times continued Friday at Arbutus Biopharma Corp. as it discontinued clinical development of AB-506, an oral capsid inhibitor, which is in a clinical trial for treating chronic hepatitis B. The decision was made when two healthy volunteers were found to have acute hepatitis.
Read More

U.K. bans certain exports to preserve drug stockpiles in case of no-deal Brexit

Oct. 7, 2019
By Nuala Moran
LONDON – The U.K. government has placed an immediate ban on the export of certain drugs in a bid to prevent wholesalers taking advantage of the fall in the value of the pound against the euro by selling off U.K. stockpiles that have been built up to protect against an interruption in supplies in event of a no-deal Brexit.
Read More

FDA approves Descovy for HIV-1 PrEP

Oct. 4, 2019

FDA approves Entresto for pediatric heart failure

Oct. 4, 2019

Trump promises quicker Medicare coverage for breakthrough technologies

Oct. 4, 2019
By Mari Serebrov
Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.
Read More

Advamed urges CMS to form Medicare advisory panel for digital health

Oct. 3, 2019
By Mark McCarty
Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."
Read More

It's not just about pricing as drug-related bills continue to pile up in Congress

Oct. 2, 2019
By Mari Serebrov
While the U.S. House and Senate push forward with controversial legislative packages aimed at making prescription drugs more affordable for Americans, other bills that would impact the biopharma sector are making their own way through Congress, being absorbed into the larger pricing packages or getting tacked on to unrelated legislation.
Read More

China three-year plan aims to put patient access to cancer drugs on par with other markets

Oct. 2, 2019
By Elise Mak
SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.
Read More

FDA approves Invokana for use in patients with type 2 diabetes and diabetic kidney disease

Oct. 1, 2019
Previous 1 2 … 975 976 977 978 979 980 981 982 983 … 1360 1361 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for April 22, 2026.
  • Man holding raised arm with illustrated overlay of nerves

    Biohaven reports details on discovery of BHV-2100

    BioWorld Science
    Transient receptor potential melastatin 3 (TRPM3) is a calcium-permeable TRP channel that is highly expressed in somatosensory neurons, including nociceptors of...
  • Elderly woman holding illustration of brain with missing puzzle piece

    Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’

    BioWorld
    The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically...
  • New GABA(B) receptor PAMs revealed in Addex Pharma patents

    BioWorld Science
    Addex Pharma SA has disclosed new GABA(B) receptor positive allosteric modulators (PAMs) potentially useful for the treatment of chronic cough, urinary...
  • MMP inhibitors divulged in Accure Therapeutics patent

    BioWorld Science
    Accure Therapeutics has reported new oligopeptide derivatives acting as matrix metalloproteinase-2 (MMP-2) and MMP-9 inhibitors. As such, they are described as...
  • 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