Summary :- Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates…
Inc
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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
The FDA has Approved TZIELDTM (Teplizumab-mzwv) as the First and Only Medication Intended to Postpone the onset of Stage 3 Type 1 Diabetes (T1D) in Adult and Paediatric Patients with Stage 2 T1D Who are 8 Years of Age and Older.
by adminby adminSummary:- TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients,…
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RegulatoryU.S FDA
Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)
by adminby adminSummary: Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide…
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RegulatoryU.S FDA
bluebird bio Receives FDA Accelerated Approval for SKYSONA®(elivaldogene autotemcel)Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
by adminby adminSynopsis: SKYSONA is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and…
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RegulatoryU.S FDA
Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection
by adminby adminSummary: First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years ROLVEDON™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and…
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RegulatoryU.S FDA
Incyte Announces FDA Approval of Pemazyre® (Pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
by adminby adminSynopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…
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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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Agro Science & Research
Iconovo Receives $883,800 Grant from the Bill & Melinda Gates Foundation
by adminby adminSummary: Iconovo has revealed that it has received a grant of $883,800 from the Bill & Melinda Gates Foundation to develop a…
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Global MarketRegulatoryU.S FDA
Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure
by adminby adminSummary : First and only nitric oxide generator and delivery system indicated for the treatment of termand near-term neonates with hypoxic respiratory…