The latest approval expands the treatment options available to eligible patients with HER2-positive breast cancer in India, covering both earlier and advanced stages of the disease
The FDA based its approval on results from a randomized, observer-blind, active-controlled Phase 3 trial that enrolled 40,805 adults across 11 countries
The FDA action applies to adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and whose tumors carry the KRAS G12C mutation
The approval makes Datroway the only TROP2-directed antibody drug conjugate approved in the EU to demonstrate an overall survival benefit in the first-line treatment of metastatic TNBC
Investigational menin inhibitor receives second orphan status, with Phase 1/2 and registrational Phase 2 studies underway in acute leukemia
The product will be manufactured at company's injectable manufacturing facility in Gujarat, and marketed in United States through Zydus Pharmaceuticals
The approval marks another milestone in the company's expanding global biosimilars portfolio and strengthens its presence in the highly regulated US biologics market
The approved product has been determined to be bioequivalent to the reference listed drug Valium Injection 10 mg/2 mL (5 mg/mL) marketed by Hoffmann-La Roche Inc
Bioequivalent version of Merck's Bridion targets the reversal of neuromuscular blockade in adult and pediatric surgical patients
The approval marks a major shift in the treatment landscape for people living with NSV
An estimated 850 million people worldwide are living with CKD
Pfizer and BioNTech said the updated monovalent XFG-adapted vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages
Day-1 launch targets USD 1.6 billion US market for neuromuscular blockade reversal drug
With an eye on USD 413 million market, the company plans to launch the product in the coming days in partnership with Hypera Pharma, one of Brazil's leading pharmaceutical companies
The approved product is therapeutically equivalent to Advair Diskus, a widely prescribed inhalation therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease
Generic version of Takeda's Motegrity addresses US$ 100 million US market
Approval covers neoadjuvant use of Enhertu in combination with THP for adults with Stage II or III HER2-positive breast cancer.
According to the company, the PIVOTAL study demonstrated that Nidlegy reduced the risk of relapse or death compared with the control arm
The approval marks the first time naproxen sodium has been combined with acetaminophen in a single nonprescription tablet
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