KEYPOINTS: The product is a generic version of the Lupin Atlantis Holdings, S A Corporation’s Antara capsules Fenofibrate Capsules (RLD: Antara Capsules)…
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Category:
Active Pharmaceutical Ingredients (API)
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AstraZenecaDapagliflozin
NICE issues Draft Recommendation for AstraZeneca`s Forxiga (Dapagliflozin) to Treat Adults with Chronic Kidney Disease
by adminby adminAbstract: The National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for AstraZeneca’s Forxiga (Dapagliflozin) within…
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Active Pharmaceutical Ingredients (API)ibuprofenparacetamol
Hyloris announces FDA Acceptance Of New Drug Application for Maxigesic IV in Post-Operative Pain.
by adminby adminHyloris Pharmaceuticals SA, a speciality biopharma company committed to addressing unmet medical needs through reinventing existing medications, announces that the U.S.…
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Active Pharmaceutical Ingredients (API)Covaxin
WHO grants Most-awaited Emergency Use Listing to Bharat Biotech’s Covaxin.
by adminby adminSUMMARY: WHO grant of EUL will ease international travel for those vaccinated with the Bharat Biotech`s Covaxin and the WHO clearance is a…
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Active Pharmaceutical Ingredients (API)ATG-101Pharma Science & Research
Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L1/4-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma.
by adminby adminKEYPOINTS; Antengene Corporation Limited announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for…
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cortrophin
ANI Pharmaceuticals Announced the FDA Approval of Purified Cortrophin™ Gel for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome.
by adminby adminKEY POINTS: The U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel…
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Iptacopan
Novartis Pharmaceuticals UK awarded an Innovation Passport for Investigational Oral Therapy Iptacopan (LNP023)
by adminby adminSUMMARY: Iptacopan has been awarded the Innovation Passport for the treatment of C3 glomerulopathy (C3G) and is currently being investigated in a…
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Asciminib
FDA approves Novartis Scemblix® (Asciminib) for Certain Patients with Philadelphia Chromosome (Ph)–positive Chronic Myeloid Leukemia.
by adminby adminKeypoints: The FDA granted accelerated approval to Asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia for 2 indications.…
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CabotegravirRilpivirine
European Commission Grants Decision for Vocabria (Cabotegravir) and Rekambys (Rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV
by adminby adminSUMMARY: ViiV Healthcare announces the European Commission Decision for Vocabria (Cabotegravir) and Rekambys (Rilpivirine) injections to be initiated with or without an…
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Pitolisant
Bioprojet’s Ozawade (Pitolisant) gets Approval for the Treatment of Excessive Daytime Sleepiness (EDS) associated with Obstructive Sleep Apnoea (OSA) in Adults.
by adminby adminSUMMARY: EMA-approved medicine for excessive daytime sleepiness med Ozawade (Pitolisant) Pitolisant was developed after decades of research by Bioprojet co-founders Dr. Jeanne-Marie Lecomte and Prof. Jean-Charles…