Keypoints: PTC Therapeutics, Inc. announced that the Brazilian National Health Surveillance Agency has approved the expansion of the indication of Translarna (Ataluren)…
Active Pharmaceutical Ingredients (API)
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Active Pharmaceutical Ingredients (API)BictegravirEmtricitabineTenofovir Alafenamide
USFDA Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
by adminby adminKeypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment…
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Active Pharmaceutical Ingredients (API)Chugai Pharmaceuticals and Oncolys BioPhamaCompaniesTelomelysin
Oncolys BioPharma and Chugai Pharmaceuticals agree to Terminate Exclusive License Agreement on Oncolytic Viral Immunotherapy, OBP-301(Telomelysin)
by adminby adminKeypoints: Chugai, Oncolys BioPharma agree to terminate exclusive license agreement on oncolytic viral immunotherapy, OBP-301 The effective date of the termination will…
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Active Pharmaceutical Ingredients (API)Lenalidomide
Dr. Reddy’s Labs receives US FDA approval for Generic Revlimid (Lenalidomide).
by adminby adminKeypoints Dr. Reddy’s Laboratories said it has received approval from the US health regulator to market Lenalidomide capsules, used to treat multiple…
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Active Pharmaceutical Ingredients (API)Varenicline
TYRVAYA (Varenicline Solution) Oyster Point’s Drug becomes First FDA-approved Nasal Spray to Treat Dry Eyes.
by adminby adminThe TYRVAYA nasal spray is the first approved nasal spray to treat dry eye disease. TYRVAYA nasal spray will benefit the patients…
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Empagliflozin
MSN Labs and Dr. Reddy`s Labs launched Patented Anti-Diabetic Pill Jardiance (Empagliflozin), leads to a Potential Legal Battle
by adminby adminKeypoints MSN Laboratories on Monday has launched the most affordable copies of Jardiance (Empagliflozin), the top-selling patented anti-diabetes pills sold by German…
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Active Pharmaceutical Ingredients (API)Macitentan & Tadalafil
Janssen’s OPSYNVI (Macitentan and Tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination.
by adminby adminKeypoints: The Janssen Pharmaceutical Company of Johnson & Johnson announced today that Health Canada approved OPSYNVI. OPSYNVI should be used in patients…
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Active Agrochemical IngredientAtezolizumab
USFDA approves Roche’s Tecentriq (Atezolizumab) as Adjuvant Treatment for Non- small Cell Lung Cancer.
by adminby adminKeypoints USFDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early NSCLC Tecentriq treatment reduced the risk of disease recurrence…
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Active Pharmaceutical Ingredients (API)Bharat BiotechCompaniesCovaxin
Covaxin approval: WHO’s technical advisory group to decide on 26 October.
by adminby adminWHO advisory group to meet on Oct 26 to decide on Bharat Biotech’s Covaxin. Covaxin manufacturer, Bharat Biotech, has been submitting data…
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AbemaciclibActive Pharmaceutical Ingredients (API)
Agilent Technologies’ Ki-67 IHC MIB-1 PharmDx assay has been approved by the FDA for use as a Companion Diagnostic to Eli Lilly’s Abemaciclib, or Verzenio.
by adminby adminKEYPOINTS The FDA has given the Ki-67 IHC MIB-1 pharmDx assay a companion diagnostic approval for detecting Ki-67 expression in patients with…