BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application submitted by BioSpecifics' partner, Auxilium...
Boston Scientific Corporation has received U.S. Food and Drug Administration and CE Mark approval for the CoverEdge? 32 and CoverEdge? X 32 Surgical Leads, the world's first 32- contact surgical leads designed to blanket the spinal cord for unprecedented pain coverage. Boston Scientific is introducing the CoverEdge Surgical Leads at the Congr
WASHINGTON- Boston Scientific Corp. Tuesday said its surgical leads- CoverEdge 32 and CoverEdge X 32- have received U.S. Food and Drug Administration approval as well as the CE Mark from European Union to provide software-guided stimulation to the spinal cord for relieving pain. The company said CoverEdge 32 and CoverEdge X were superior to existin
WASHINGTON- Auxilium Pharmaceuticals Inc.' s supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit has been approved by FDA. Auxilium Pharma is all set to be acquired by Endo International plc for roughly $2.6 billion, and the transaction is expe
Release date- 20102014- Basel,- Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration today voted unanimously to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemi
According to a recent FDA announcement, some medical professionals are reportedly using an HA-based formula as a dermal filler despite the fact it is not designed for this purpose. The FDA alert states that a hyaluronic acid-based gel called Expression or Expression Injectable, which is designed for use as an intranasal splint for rhinoplasty, has
On October 21, 2014, Tonix Pharmaceuticals Holding Corp. issued a press release announcing that the Company has received clearance from the U.S. Food and Drug Administration of its Investigational New Drug application to study TNX-201 for the treatment of episodic tension-type headache. A clinical pharmacology study of TNX-201 in healthy volunteers
Tonix Pharmaceuticals Holding Corp. announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to study TNX-201 for the treatment of episodic tension-type headache. Tonix will evaluate the safety, tolerability, and pharmacokinetics of TNX-201 in a healthy volunteers study to be completed before
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has received 510 clearance of the Vial2Bag DC device from the United States Food and Drug Administration, and also the CE Mark for the European Union. Our new Vial2Bag DC device simplifies the IV admixture process and eliminates the
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. XIAFLEX is a biologic approved in the U.S.,
By a News Reporter-Staff News Editor at Pharma Business Week BioDelivery Sciences International, Inc. will host an investor update conference call and webcast to discuss the launch of BUNAVAIL? buccal film which has been approved by the U.S. Food and Drug Administration for the maintenance treatment of opioid dependence. Since FDA approval of B
Boehringer Ingelheim Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. According to a release from the Company, granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the
Dexcom, Inc., a leader in continuous glucose monitoring for patients with diabetes, announced today that it has received U.S. Food and Drug Administration approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important gluco
CHICAGO& NEW YORK Link to Fitch Ratings' Report: Global Pharmaceutical R&D Pipeline. The number of NME approvals by the FDA during the first nine months in 2014 was up from the first nine months of 2013. The FDA cleared 33 novel medicines for U.S. marketing during the first five months of 2014, compared with 17 in 2013. The FDA has approved sev
Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 for patients with moderate-to-severe plaque psoriasis. Novartis International AG/ Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 for patients with moderate-to-severe plaque psoriasis. 17 A inhibitor, is currently under FDA...
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has approved new contract manufacturing facilities used in the production of Hylenex recombinant. The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in H
Oct. 20 NAPLES Voters will consider making Florida the 24th state and the first in the South to approve a comprehensive medical marijuana program, but opponents argue a synthetic form of marijuana already offers medical relief that's controlled by the Food and Drug Administration. The debate over medical marijuana in Florida has raged between s
By a News Reporter-Staff News Editor at Pharma Business Week Neovasc Inc. announced that it has received conditional Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara? transcatheter mitral valve. "We are delighted that aft
There is a need for novel therapies as not all treatments are appropriate or effective in every patient, "said Vas Narasimhan, Global Head Development, Novartis Pharmaceuticals. We look forward to working with the FDA as it finalizes its review. " In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area an
OssDsign AB today announced that its bioceramic burr hole plug- Cranioplug- has received 510 clearance by the US Food and Drug Administration. The clearance from the FDA demonstrates OssDsign can effectively navigate the FDA regulatory process and access the world s largest market. This is a good example of how a management team with a proper bl
Release date- 17102014- Pfizer Inc. announced today that the United States Food and Drug Administration has approved an updated label for EMBEDA extended-release capsules, for oral use, CII, to include abuse-deterrence studies. Pfizer expects EMBEDA will be available in the U.S. in early 2015.. However, misuse and abuse of opioids in the U.S. is a
Vesiflo reported that its Direct De Novo Petition for the inFlow Urinary Prosthesis has been granted by the U.S. Food and Drug Administration, allowing the inFlow to be freely marketed in the U.S. According to a release from the company, the inFlow is a non- surgical device that provides a convenient and dignified alternative to urinary catheters.
? ?We are pleased that DANA has sought and received FDA clearance, leading the way for this type of game-changing technology, ? said Corinna Lathan, founder and CEO of AnthroTronix. ? ?In essence, measuring reaction time is like taking the temperature of the brain? like a' Brain Thermometer'? and it is a vital par
Vivolux reported that the FDA recently granted clearance to proceed with VLX1570 to clinical phase I/II for treatment against relapsed and/or refractory multiple myeloma. Vivolux said that the clinical study will be conducted in collaboration with the Memorial Sloan-Kettering Cancer Center and the Dana-Farber Cancer Institute at Harvard Medical...
Regeneron Pharmaceuticals said that the U.S. Food and Drug Administration has approved Eylea Injection for the treatment of Macular Edema following Retinal Vein Occlusion, which includes Macular Edema following Branch Retinal Vein Occlusion in addition to the previously-approved indication of Macular Edema following Central Retinal Vein Occlusion.