You are here: Industry Insights > FDA

News List

FDA to review Dupixent® (dupilumab) as potential treatment for moderate-to-severe asthma worldpharmanews
March 13, 2018
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application of Dupixent® (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-s
Sarepta to Seek FDA Approval for Second DMD Treatment biospace
March 13, 2018
Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) is planning on seeking approval of a second treatment for Duchenne muscular dystrophy (DMD).
BMS(nivolumab) now the first and only FDA-approved PD-1 inhibitor of every four-week dosing worldpharmanews
March 12, 2018
Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4
FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance s biospace
March 12, 2018
The U.S. Food and Drug Administration today issued a warning letter to all three manufacturers of duodenal mirrors
FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder biospace
March 12, 2018
Yesterday, the FDA approved the conduct of a pivotal clinical trial using a new technology to treat overactive bladder.
FDA warns of fraudulent and unapproved flu products FDA
March 09, 2018
As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu.
FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch biospace
March 09, 2018
Polyganics, today announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch.
InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spi biospace
March 09, 2018
InVivo Therapeutics Holdings Corp. (NVIV) announced today that the company has been approved by the U.S. Food and Drug Administration (FDA) for a supplementary research equipment exemption (IDE).
FDA greenlights alternative therapy for multidrug-resistant HIV patients pharmafile
March 08, 2018
Theratechnologies has revealed that Trogarzo has received approval from the FDA as a treatment of HIV-1 in patients with multidrug-resistant infection.
WuXi Biologics Congratulates TaiMed on FDA Approval for Trogarzo prnasia
March 08, 2018
Wuxi Biopharmaceutical congratulates its partner Taimai Biological Products Co., Ltd. for obtaining FDA approval of Trogarzo (ibalizumab)

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page