Highlights: Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the…
Chronic
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RegulatoryU.S FDA
Axsome Therapeutics Auvelity(dextromethorphan HBr -bupropion HCl) Becomes the First FDA-Approved Oral NMDA for Major Depression
by adminby adminSummary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral…
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AstraZenecaRegulatoryU.S FDA
FDA says no to AZ’s Fasenra for nasal polyp indication
by adminby adminSummary : AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic…
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CompaniesGskPharma Science & Research
GSK’s Bad Week: Maternal RSV Vaccine Paused, Trade Secrets Violation Alleged
by adminby adminSynopsis: GlaxoSmithKline has voluntarily paused activities in its Phase III GRACE trial on an experimental maternal vaccine for respiratory syncytial virus (RSV).…
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Agrochemicals
FDA Grants AppliedVR Approval for First Virtual Reality Therapeutic to Treat Chronic Low Back Pain.
by adminby adminSUMMARY: The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive…
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Mepolizumab
GlaxoSmithKline`s Nucala (Mepolizumab) gets European Approval for use in Three Additional Eosinophil-driven Diseases.
by adminby adminKEYPOINTS: GlaxoSmithKline (NYSE:GSK) announces that the European Commission has approved Nucala (Mepolizumab), a monoclonal antibody that targets interleukin-5, for use in three…
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Agrochemicals
Cipla launches ‘Spirofy’, Pneumotach-Based Portable Wireless Spirometer for Early Diagnosis of COPD
by adminby adminKEYPOINTS: Spirofy is India’s first pneumotach-based portable wireless Spirometer for the diagnosis of COPD and asthma. The company intends with this launch…
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Gsk
GlaxoSmithKline’s Novel Anemia (Daprodustat) has Notched up A First-In-Class Success While AstraZeneca-FibroGen’s Akebia Failed.
by adminby adminSYNOPSIS: GlaxoSmithKline Plc released positive trial results for a potential blockbuster anemia pill the company is hoping will bolster its pharma portfolio…
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AstraZenecaDapagliflozin
NICE issues Draft Recommendation for AstraZeneca`s Forxiga (Dapagliflozin) to Treat Adults with Chronic Kidney Disease
by adminby adminAbstract: The National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for AstraZeneca’s Forxiga (Dapagliflozin) within…
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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…