TG Therapeutics Announces FDA Approval of BRIUMVI™ (Ublituximab-xiiy)
Summary:- BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be…
Regulatory
FDA Approves Adstiladrin , First Gene Therapy for the Treatment of High-risk, Non-muscle-invasive bladder cancer to Ferring Pharmaceuticals
Summary:- 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…
Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV
Summary :- Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates…
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
Summary :-Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted…
Indian Farmers Fertiliser Cooperative Limited and Mitsubishi Corporation Launches Takibi (Flubendiamide 20% WG) Insecticide
Highlights : IFFCO and Mitsubishi Corporation formed a joint venture to produce Tabiki (Flubendiamide 20% WG). The major causes of biotic stress…
INDIAN PESTICIDE APPROVALS – 442ND RC MEETING – CHLORANTRANILIPROLE – FMC MOLECULE – MAJOR HIGHLIGHT
INDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 442ND REGISTRATION COMMITTEE (RC) MEETING HELD ON 18.11.2022 The 442nd meeting of the Registration…
FDA Approves First-in-Class Microbiota-Based Live Biotherapeutic for C. Difficile Infection
Summary- The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18…
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.
Summary:- TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients,…
Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)
Summary: Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide…
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for relapsed or Refractory Multiple Myeloma
Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for…