KEYPOINTS Sun Pharmaceutical Industries is getting set to bring out its version of molnupiravir, the anti-viral drug from Merck Sharpe Dohme and…
Approval
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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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Agrochemicals
Pfizer-BioNTech became the First FDA Authorized COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
by adminby adminKEYPOINTS FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. Effectiveness: Immune responses of children…
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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…
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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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432 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN PESTICIDE APPROVAL UPDATES: 432nd RC MEETING [CIBRC]
by adminby adminMINUTES OF THE 432nd REGISTRATION COMMITTEE MEETING HELD ON 24.09.2021. The 432nd meeting of the Registration Committee (RC) was held under the…
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CompaniesPfizerPharma Science & Research
Pfizer-BioNTech asked for Approval from The EU Agency for Vaccination of Kids 5-11.
by adminby adminKeypoints Pharmaceutical company Pfizer and biotechnology company BioNTech have requested to have their coronavirus vaccine licensed for children ages 5 to 11…
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Agrochemicals
US FDA’s Center for Drug Evaluation and Research (CDER) – Novel Drug Approvals for 2021
by adminby adminUS FDA’s Center for Drug Evaluation and Research (CDER) – Novel Drug Approvals for 2021 Innovation drives progress. When it comes to…
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414 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updatesRegulatory
NEW NORMAL AFTER COVID-19 – CIBRC 414TH RC MEETING HELD THROUGH VIDEO CONFERENCE
by adminby adminNEW NORMAL AFTER COVID-19 – CIBRC 414TH RC MEETING HELD THROUGH VIDEO CONFERENCE. The major updates – CIBRC approval in the various…