March 10, 2017
Mylan to sell major depressive disorder tablets in US
Mylan has launched Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer’s Pristiq Tablets in U.S..
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
March 9, 2017
Servier cleared for UCART development in the USA
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.
March 8, 2017
Alexion waits for FDA’s OK for generalized myasthenia gravis drug
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.
February 27, 2017
Valeant’s Bausch + Lomb and Nicox reapply for their eye drug
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%.
February 23, 2017
Novartis’s cancer drug wins FDA’s sNDA, priority review and breakthrough therapy designation
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.
February 22, 2017
BD in new performance standards to improve influenza testing quality
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.
February 16, 2017
Valeant wins FDA’s approval for psoriasis drug
The U.S. Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals’s Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
February 15, 2017
Pharma industry shuns Trump push for radical shift at FDA
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.
February 9, 2017
FDA approves Marathon Pharmaceuticals’s orphan drug
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.
February 9, 2017
Tetraphase antibiotic may reach up to $700 million in annual sales: CEO
Tetraphase Pharmaceuticals Inc Chief Executive Guy Macdonald said annual sales of the company’s lead experimental antibiotic for serious bacterial infections could climb as high as $700 million if approved.