Chiesi and Protalix’s Therapy for Fabry Disease Receives Marketing Approval from EC
Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc. have received marketing authorization from the European Commission (EC) for their drug,
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Regulatory
Janssen Claims First Global Approval for AKEEGA®
Janssen has received its first worldwide approval for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) as EC Authorized treatment
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FDA Grants Fast Track Designation for Shionogi’s Investigational COVID-19 Oral Antiviral
Japanese multinational pharmaceutical company Shionogi & Co., Ltd,. announced at the beginning of April that the U.S. FDA has granted
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FDA Grants EUA for InflaRx’s Gohibic (vilobelimab) to Treat Critically Ill COVID-19 Patients
InflaRx N.V., a biopharmaceutical company in the clinical stage of developing anti-inflammatory therapeutics that target the complement system, has announced
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Bristol Myers Squibb’s Reblozyl® (luspatercept) Approved by EC for Anemia in Adults with NTDT
American multinational pharmaceutical company Bristol Myers Squibb announced on Friday that the European Commission (EC) has awarded the company with
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Akorn Pharmaceuticals Investigated Following Bankruptcy and Abrupt Mass Layoffs
Ilinois-based pharmaceutical company Akorn Operating Co., is under investigation by the Illinois Department of Labor (IDOL), following the company’s filing
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AstraZeneca’s Forxiga Gets EU Approval for the Treatment of Chronic Heart Failure
The European Union has authorized AstraZeneca’s Forxiga (dapagliflozin) to expand the treatment for heart failure (HF) with reduced ejection fraction
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EC Approves Sanofi and Regeneron’s Dupixent® for Eosinophilic Esophagitis
The European Commission has authorised Sanofi and Regeneron’s Dupixent® (dupilumab) as the first and only therapeutic therapy for eosinophilic esophagitis.
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AstraZeneca and Amgen’s TEZSPIRE® Approved for Self-administration in the US
The U.S. Food and Drug Administration (FDA) has approved AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) for self-administration in a pre-filled, single-use
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FDA Grants EUA for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as
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