Regulatory | 16 December 2021
U.S. FDA approves Bristol Myers Squibb’s Orencia
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.
Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
The tablets are indicated for the treatment of pulmonary arterial hypertension
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90
Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients
Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever
The product will be commercialized from Unichem's Ghaziabad plant
This further adds to Biocon’s portfolio of vertically integrated complex drug products
It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults
The company is marketing the kit under the brand name CoviFind and it can detect the infection in 15 minutes
The approval is for Cytomegalovirus, a type of Herpes virus
Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
Subscribe To Our Newsletter & Stay Updated
