Synopsis:- 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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RegulatorySetmelanotideU.S FDA
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (Setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
by adminby adminSummary : IMCIVREE now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic…
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Active Pharmaceutical Ingredients (API)CompaniesGlobal MarketPAXLOVIDPfizer
After Watershed Year, Pfizer Expects Revenue to Top $98B in ’22
by adminby adminSummary : Pfizer Chief Executive Officer Albert Bourla called 2021 a watershed year for the company. It posted $81.3 billion in revenue…
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Active Pharmaceutical Ingredients (API)CompaniesGlobal MarketPAXLOVIDPfizer
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
by adminby adminSummary : EMA’s human medicines committe has recommended granting conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 / ritonavir) for…
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Maribavir
Takeda’s LIVTENCITY (Maribavir) Approved by U.S. FDA as the First and Only Treatment of Post-Transplant Cytomegalovirus (CMV), that is Resistant to other Antiviral Drugs.
by adminby adminSYNOPSIS: Takeda announced that U.S. FDA Approved LIVTENCITY (Maribavir) as the First and Only Treatment for People Ages 12 or older and…
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CompaniesPfizerTofacitinib
Pfizer’s XELJANZ® (Tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis
by adminby adminAbstract: The European Commission has approved Pfizer`s first-of-its-kind oral Janus kinase (JAK) inhibitor XELJANZ® (Tofacitinib) 5 mg twice daily for the treatment…
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Nelarabine
Zydus Cadila receives USFDA Final Approval for Nelarabine Injection a Therapeutically Generic Version of Arranon injection.
by adminby adminKEYPOINTS: Zydus Cadila has received final approval from the US FDA to market Nelarabine injection 250MG/50ML in the United States. Zydus Pharmaceuticals…
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