The U.S. Food and Drug Administration (FDA) on Friday approved Biogen and Sage Therapeutics oral pill to treat postpartum depression (PPD) in…
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2023 ApprovalsMarch 2023NovartisPharma ApprovalsU.S FDA
March 2023 Approval Update – Pharming’s Leniolisib Gains FDA Approval for Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
by adminby adminSynopsis:- Joenja is the first drug approved in the U.S. for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in…
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2023 ApprovalsMarch 2023Pharma ApprovalsU.S FDA
March 2023 Approval Update – DAYBUE™ (Trofinetide) from Acadia Pharmaceuticals has Received U.S. FDA Approval for the Treatment of Rett syndrome in Adult and Paediatric patients Two years of age and older.
by adminby adminSynopsis First and only approved therapy for Rett syndrome, a rare, neurodevelopmental disorder, which affects 6,000 to 9,000 patients in the U.S.…
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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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RegulatoryU.S FDA
TG Therapeutics Announces FDA Approval of BRIUMVI™ (Ublituximab-xiiy)
by adminby adminSummary:- BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be…
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RegulatoryU.S FDA
FDA Approves Adstiladrin , First Gene Therapy for the Treatment of High-risk, Non-muscle-invasive bladder cancer to Ferring Pharmaceuticals
by adminby adminSummary:- Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer Efficacy and safety of Adstiladrin supported…
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GileadRegulatoryU.S FDA
Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV
by adminby adminSummary :- Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates…
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Mirati TherapeuticsRegulatoryU.S FDA
Mirati Therapeutics Announces U.S. FDA Accelerated Approval of KRAZATI™ (adagrasib) as a Targeted Treatment Option for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
by adminby adminSummary :-Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted…
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RegulatoryU.S FDA
FDA Approves First-in-Class Microbiota-Based Live Biotherapeutic for C. Difficile Infection
by adminby adminSummary- The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18…
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