Pharmaceuticals, Biotechnology and Life Sciences
The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration’s proposed 2018 budget.
Mylan has launched Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer’s Pristiq Tablets in U.S..
Servier has been cleared with Investiga New Drug (IND) by the U.S. Food and Drug Administration (FDA) for the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.
U.S. Food and Drug Administration(FDA) has accepted for review the Alexion Pharmaceuticals’s supplemental Biologics License Application (sBLA) to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Valeant Pharmaceuticals`s subsidiary, Bausch + Lomb, and Nicox have resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for latanoprostene bunod ophthalmic solution, 0.024%.
US Food and Drug Administration (FDA) has accepted Novartis’s supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
BD said on Wednesday that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new Food and Drug Administration’s (FDA’s) performance requirements.
The U.S. Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
U.S. President Donald Trump’s vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.
The U.S. Food and Drug Administration (FDA) has approved Marathon Pharmaceuticals’s Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness.