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Statement from the Chief Public Health Officer of Canada on April 1, 2022
4/1/2022
The Public Health Agency of Canada continues to monitor COVID-19 epidemiological indicators to quickly detect, understand and communicate emerging issues of concern.
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FDA Roundup: April 1, 2022
4/1/2022
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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XORTX Files IND with US FDA
3/31/2022
XORTX Therapeutics Inc., a pharmaceutical therapeutics company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the filing of an investigational new drug application with the Unites States Food and Drug Administration.
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T2 Biosystems Announces BARDA Exercise of Contract Option 2B Valued at $4.4 Million
3/31/2022
T2 Biosystems, Inc. announced that the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, is providing an additional $4.4 million in funding for the multiple-year cost-share contract between BARDA and T2 Biosystems.
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Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
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Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
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Civica plans to make versions of three affordable insulins available at significantly reduced costs by 2024. You can explore the other aspirations here in this article.
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Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy
3/29/2022
Pratteln, Switzerland, March 29, 2022 – Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the initiation of a rolling new drug application submission to the U.S. Food and Drug Administration for vamorolone for the treatment of Duchenne muscular dystrophy.
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In his State of the Union Address earlier this year, President Joe Biden called for a $35 cap on insulin costs that are provided by insurance programs.
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COVID-19 vaccines are the most-studied vaccines in history. This is partly why some data can appear so contradictory. For those and more COVID-19 stories, continue reading.
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FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs
3/28/2022
The U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President's fiscal year 2023 budget – a nearly 34% increase over the agency's FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.
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STAAR Surgical Announces U.S. FDA Approval of EVO Visian® Implantable Collamer® Lenses
3/28/2022
STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, announced that the U.S. Food and Drug Administration has granted approval of the EVO/EVO+ Visian® Implantable Collamer® Lens for the correction of myopia and myopia with astigmatism.
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Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies
3/26/2022
Adults with severe alopecia areata who took OLUMIANT® achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to OLUMIANT 4-mg achieved 90% scalp coverage at 52 weeks, Eli Lilly and Company and Incyte announced at the American Academy of Dermatology Annual Meeting.
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Automation in pharmaceutical industry can make the companies target of the cyber threats emanating from Russia, China, and North Korea. It can be collateral or direct.
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Statement from the Chief Public Health Officer of Canada on March 25, 2022
3/25/2022
The Public Health Agency of Canada continues to monitor COVID-19 epidemiological indicators to quickly detect, understand and communicate emerging issues of concern.
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Libtayo® (cemiplimab) now approved in Canada for the treatment of recurrent or metastatic cervical cancer
3/25/2022
sanofi-aventis Canada Inc. announced the approval of Libtayo® for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease.
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Visby Medical Executes Contract Option with BARDA for $25.5M to Develop Rapid Flu-COVID PCR Test Designed for At-Home Use
3/25/2022
Visby Medical™, a leading medical diagnostic company, announced that it has received an additional $25.5M in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority.
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A federal judge in Delaware tossed out a lawsuit by Genentech, Inc., a Roche company, accusing Novartis' Sandoz division of patent infringement.
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In honor of March 24, World TB Day, BioSpace looks at clinical trials and eradication efforts occurring today.
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Health Canada authorizes Héma-Québec submission to make source plasma donor screening criteria more inclusive for men who have sex with men
3/24/2022
Health Canada authorized a submission from Héma-Québec to change their source plasma donor screening criteria.