Synopsis: CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as…
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RegulatoryU.S FDAZydus Cadila
USFDA Grant Orphan Drug Designation to Zydus ZY19489 Antimalarial Compound.
by adminby adminSynopsis- The ZY19489 is a novel antimalarial compound active against all current clinical strains of malaria-causing microorganisms ‘P. falciparum’ and ‘P. vivax’,…
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RegulatorySun PharmaU.S FDA
USFDA Approves Generic Amphotericin B Liposome for Injection Manufactured By Sun Pharma
by adminby adminSynopsis- Sun Pharmaceuticals Industries announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New…
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Approves AstraZeneca’s Evusheld becomes First Authorized COVID Antibody to Protect the Immunocompromised Before Exposure
by adminby adminSummary : With the FDA’s emergency use authorization today of AstraZeneca’s long-acting antibody cocktail, the roughly 2% of U.S. residents who are…
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RegulatoryU.S FDA
On Target Laboratories has received FDA Approval for the Injectable CYTALUXTM (Pafolacianine) for the Detection of Ovarian Cancer during Surgery.
by adminby adminThe FDA has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions, according to…
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FDA approved Genentech’s Susvimo, a port delivery system with a customized formulation of Ranibizumab, the active ingredient in Lucentis. Now, the trick for…
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RegulatoryU.S FDA
U.S. Approved Bausch, Clearside XIPERE™ (Triamcinolone Acetonide )Injectable Suspension
by adminby adminBausch Health Companies Inc and Clearside Biomedical Inc said on Monday they received approval from the U.S. health regulator for their…
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RegulatoryU.S FDA
USFDA Panel endorses Johnson and Johnson COVID-19 Vaccine booster.
by adminby adminKeypoints J&J presented data to the 19-member committee indicating that its vaccine loses efficacy over time, and that a booster shot is…
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