The U.S. Food and Drug Administration(FDA) today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
The US Food and Drug Administration (FDA) has approved a device designed to reduce the symptoms of opioid withdrawal.
A man may soon be forever free of the previously incurable disease he was born with 44 years ago. On Monday, in a medical first, Brian Madeux received an experimental in-body gene-editing treatment intended to cure him of Mucopolysaccharidoses II, known as MPS II or Hunter syndrome, a rare disorder that causes progressive damage to the body's cells.
Loxo Oncology struck a deal with Germany-based Bayer AG to develop and commercialize two cancer therapies in a deal that could be worth up to $1.55 billion for the Connecticut-based company.
Real-world outcomes among patients with atrial fibrillation taking the anticoagulant dabigatran (Pradaxa) mimic those reported in clinical trials, with dabigatran use associated with lower rates of brain bleeds, and similar rates of stroke and extracranial hemorrhage as treatment with warfarin in a new study.
A decade ago, the medical world was shocked when a patient in Berlin, Germany, had been declared free of HIV after receiving a stem cell transplant to treat cancer. Doctors have repeatedly tried to replicate the result, but this HIV cure has evaded other patients so far.
Seattle Genetics, Inc. (SGEN) announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Novartis is blazing ahead with its bid to take its new CAR-T therapy, Kymriah, into new realms with a double-pronged approval application in Europe.
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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