https://www.gsk.com/en-gb/media/press-releases/us-fda-expands-jemperli-dostarlimab-plus-chemotherapy-approval-to-all-adult-patients-with-primary-advanced-or-recurrent-endometrial-cancer/
Jemperli approval now includes MMRp/MSS tumours, which represent majority of endometrial cancer cases.
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https://www.businesswire.com/news/home/20231129194008/en/US-FDA-Grants-the-BiVACOR-Total-Artificial-Heart-IDE-Approval-for-First-in-Human-Early-Feasibility-Study
BiVACOR receives FDA approval with investigational device exemption to conduct early feasibility studies of its Total Artificial Heart
total artificial heartus fdagrantsideapproval
https://cyprus-mail.com/2023/10/05/us-fda-panel-gives-thumbs-down-on-approval-for-amgen-lung-cancer-drug
Advisers to the U.S. Food and Drug Administration on Thursday found that data from a late-stage trial was not reliable enough to support traditional approval...
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https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia
VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia, a condition impacting…...
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https://www.pharmaceutical-technology.com/news/pfizer-approval-fda-paxlovid/
Pfizer has submitted a NDA to the US FDA seeking approval for Paxlovid to treat Covid-19 patients at increased disease progression risk.
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https://www.jpost.com/health-and-wellness/article-728578?ms=EM_NBI_CHE_20231218_BLOG_YearReview_12MO_NA_NA_WaynePacelle_na_na_Review&emci=d81bb6c6-af9d-ee11-bea1-002248223f36&emdi=ea000000-0000-0000-0000-000000000001&ceid=
Called the FDA Modernization Act 2.0, the bill, signed into law by US President Joe Biden, saw support from Republicans and Democrats alike.
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https://www.techtimes.com/articles/288885/20230313/pfizers-fast-acting-nasal-spray-migraine-treatment-gets-approval-fda.htm
Pfizer has released a statement that their fast-acting nasal spray for migraine treatment has been approved.
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https://www.business-standard.com/markets/news/cipla-rallies-4-on-usfda-approval-to-market-lanreotide-injection-124052200690_1.html
The approval for the generic version of Lanreotide Acetate is in line with Cipla's growth strategy in the complex product segment and will strengthen Cipla's...
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https://www.fox5dc.com/news/some-in-us-getting-covid-boosters-without-fda-approval
The U.S. government has not yet approved booster shots against the virus, saying it has yet to see evidence they are necessary.
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