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US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review pharmaceutical-business-review
February 14, 2022
The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.
FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management FDA
February 11, 2022
The U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
FDA Postpones Decision on Pfizer COVID Vaccine for Kids Under 5 drugs.com
February 11, 2022
The U.S. Food and Drug Administration announced Friday that it will postpone an advisory panel meeting that was slated...
FDA Grants Emergency Use Authorization for New Antibody Drug drugs.com
February 11, 2022
The U.S. Food and Drug Administration on Friday gave the nod for a new monoclonal antibody treatment that works against the Omicron variant.
U.S. Buys 600,000 Doses of New COVID-19 Treatment Still Awaiting FDA Approval drugs.com
February 11, 2022
The U.S. government has bought 600,000 doses of a new antibody drug called bebtelovimab that seems able to beat back the omicron...
FDA Postpones Decision on Pfizer COVID-19 Vaccine for Under 5s drugs.com
February 11, 2022
The U.S. Food and Drug Administration announced Friday that it will postpone an advisory panel meeting.
Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA EuropeanPharmaceuticalReview
February 10, 2022
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
FDA Raises Concerns About China-Developed Drugs FirstWordPharma
February 10, 2022
A negative FDA staff report for Eli Lilly and partner Innovent Biologics' anti-PD-1 cancer drug sintilimab could slow the plans of large Western drugmakers such as Novartis looking to sell Chinese-tested medicines...
Cabenuva HIV treatment approved for eight week dosing EuropeanPharmaceuticalReview
February 09, 2022
ViiV Healthcare has announced the US Food and Drug Administration’s (FDA) approval of Cabenuva (cabotegravir, rilpivirine) in the treatment of HIV.
CDER BIMO GCP Compliance and Enforcement FDA
February 09, 2022
This webinar will:provide a general overview of the Bioresearch Monitoring (BIMO) program...

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