Synopsis: BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZOGO™ (Vosoritide) for Injection, indicated…
Approved
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Agrochemicals
Sun Pharma Plans to Launch Merck’s Covid pill Molnupiravir Under the Brand Name Molxvir® in India Soon.
by adminby adminKEYPOINTS Sun Pharmaceutical Industries is getting set to bring out its version of molnupiravir, the anti-viral drug from Merck Sharpe Dohme and…
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Agrochemicals
Kerala’s Native herb ‘Manathakkali’ (Solanum nigrum) Approved for Liver Cancer, Research gets US FDA Nod.
by adminby adminKEYPOINTS: ‘Manathakkali’ (Black nightshade or Solanum nigrum), a berry-bearing shrub found in the backyard, is traditionally known for its medicinal value. Two scientists…
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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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Bharat Biotech
Australia has added Bharat Biotech’s Covaxin to the approved list of COVID vaccines.
by adminby adminKEYPOINTS: Australia’s medicines and medical devices regulator on Monday formally recognised India’s Covaxin, a vaccine against the coronavirus as the country’s border…
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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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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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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…
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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…