Overview To make up for arbitrary delays in the issuing of patents by the Canadian Intellectual Property Office, Canada has passed laws…
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EMA
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Astellas’ VEOZAH™ (Fezolinetant) Gets U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
by adminby adminOn May 12, the U.S. Food and Drug Administration (FDA) approved VEOZAHTM (Fezolinetant), 45 mg once daily for the treatment of moderate…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Lexicon’s INPEFA™(Sotagliflozin) Notch FDA Approval for Treatment of Heart Failure
by adminby adminSummary:- INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or…
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CompaniesEuropeEurope Medicine Agency (EMA)Pfizer
Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First ever Marketing Authorization by European Commission for both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine
by adminby adminSummary : Pfizer Inc. and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the European Commission (EC) has granted marketing…
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EuropeEurope Medicine Agency (EMA)
Myovant Sciences Announces European Commission Approval for ORGOVYX® (Relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer
by adminby adminSummary : ORGOVYX® is the first and only oral and rogend privation therapy for advanced hormone-sensitive prostate cancerin Europe Myovant expects to secure European…
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Europe Medicine Agency (EMA)Regulatory
EMA establishes a Cancer Medicines Forum to optimize Cancer Treatments in Clinical practice
by adminby adminSummary EMA has launched the Cancer Medicines Forum (CMF) in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).…
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AstraZenecaCompaniesGlobal MarketPharma Science & Research
AstraZeneca in the News: EMA Greenlights RSV Vaccine, Leif Johansson Departing
by adminby adminSummary : AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency. Nirsevimab was…
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In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised…
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Global MarketPharma Science & Research
Lilly, Roche Push Back Against CMS Draft Guidance on Aduhelm
by adminby adminSummary The U.S. Centers for Medicare & Medicaid Services (CMS) just completed the open comment period for their draft national coverage decision…
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BiogenGlobal Market
Biogen Officially Weighs in On Medicare Draft Guidance for Aduhelm
by adminby adminSummary – In mid-January, the Centers for Medicare & Medicaid Services (CMS) issued a draft national coverage decision for Biogen’s Alzheimer’s drug…
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