Synopsis : Received notification to Review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough…
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RegulatoryU.S FDA
Intra-Cellular gets another FDA Nod for Caplyta, this time for Bipolar Disorder
by adminby adminSynopsis: 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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434 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN PESTICIDE APPROVAL UPDATES: 434th RC MEETING [CIBRC]
by adminby adminMINUTES OF THE 434th REGISTRATION COMMITTEE MEETING HELD ON 30.11.2021. The 434th meeting of the Registration Committee (RC) was held under the…
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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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Cipla healthcare has launched Naselin antiviral nasal spray with Povidone Iodine that can offer the first line of defence against the COVID-causing…
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Global MarketLaunch
Glenmark Pharmaceutical Launches First New Combination Drug for Type-2 Diabetes.
by adminby adminGlenmark Pharmaceuticals on Tuesday said it has launched a fixed-dose combination drug for the treatment of Type 2 diabetes in the country.…
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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…