USFDA

Strides receives USFDA approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules

  • Posted on: 10 July 2020
  • By: PharmaTutor News

Strides Pharma Science Limited (Strides) announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA).

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.

FDA approves BAVENCIO as treatment for Metastatic Urothelial Carcinoma

  • Posted on: 1 July 2020
  • By: PharmaTutor News

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

FDA Approves New Therapy for Dravet Syndrome

  • Posted on: 26 June 2020
  • By: PharmaTutor News

The U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment.

Biocon Biologics Receives DCGI Approval for Emergency Use of CytoSorb® to Treat Critical COVID-19 Patients

  • Posted on: 27 May 2020
  • By: PharmaTutor News

Biocon Ltd an innovation-led global biopharmaceuticals company, announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb® to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

Cipla receives final approval for generic version of Migranal®

  • Posted on: 22 May 2020
  • By: PharmaTutor News

Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) designation. Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.

FDA grants priority review of Sanofi’s biologics license application for sutimlimab

  • Posted on: 18 May 2020
  • By: PharmaTutor News

The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.

FDA nods nivolumab with ipilimumab as first line treatment of metastatic non-small cell lung cancer

  • Posted on: 18 May 2020
  • By: PharmaTutor News

Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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