By a News Reporter-Staff News Editor at Pain& Central Nervous System Week- Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced that the U.S. Food and Drug Administration has approved ARYMO? ER extended-rele
By a News Reporter-Staff News Editor at Pharma Business Week- ResMed announced at the 35th annual J.P. Morgan Healthcare Conference that the U.S. Food and Drug Administration has cleared ResMed's AirMini, the world's smallest continuous positive airway pressure device. ResMed's tiny yet fully-featured AirMini, to be launched later this year, is d
By a News Reporter-Staff News Editor at Pharma Business Week Orthofix International N.V., a diversified, global medical device company, announced U.S. Food and Drug Administration and European CE Mark approvals for its next-generation CervicalStim? and SpinalStim? bone growth stimulators. "Patient recovery is often dependent on how well they
SAINT HELIER- AbbVie's blockbuster blood cancer drug Imbruvica has been approved by the FDA for yet another indication- this time, for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. Adamis Pharmaceuticals Corp.' s resubmitted New Dr
Amplitude Surgical, a leading French player on the global surgical technology market for lower-limb orthopedics, today announces that it has received 510 regulatory clearance from the US Food and Drug Administration for its Anatomic implant, addressing degenerative knee disorders. Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says:
Release date- 19012017- East Windsor, N.J.- Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited's Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg to be bioequivalent
By a News Reporter-Staff News Editor at Drug Week- Lannett Company, Inc. announced that it received approval last week from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Lopinavir and Ritonavir Oral Solution USP, 80 mg/20 mg per mL, the therapeutic equivalent to the reference listed drug, Kaletra Oral Soluti
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly- Luminex Corporation announced that it has received FDA clearance for the ARIES Group B Streptococcus Assay for antepartum detection of GBS colonization in pregnant women. This is the third assay the FDA has cleared for use on the Luminex ARIES Systems. "We found the Luminex
-Obalon Therapeutics Inc., a vertically integrated medical technology company, announced today that they will be ringing the Nasdaq Stock Market closing bell, to recognize the recent launch of the Obalon Balloon System, the first and only FDA- approved swallowable, gas-filled intragastric balloon for weight loss. On September 8th, Obalon received a
UPPSALA, Sweden, Jan. 20, 2017/ PRNewswire/ OssDsign AB, a Swedish designer, manufacturer and distributor of next generation implants for cranial and facial reconstruction, today announced that it has received 510 clearance by the US FDA for marketing and sale of OSSDSIGN Cranial PSI in the USA.. Anders Lundqvist, CEO of OssDsign, said: "Recei
Teva Pharmaceutical Industries Ltd. today announced the U.S. Food and Drug Administration approved VANTRELATM ER extended-release tablets formulated with Tevas proprietary abuse deterrence technology. Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by...
This BlueStar option will allow WellDoc more flexibility in offering the product through additional channels to adults living with type 2 diabetes. This FDA clearance is a significant milestone for WellDoc, said Kevin McRaith, WellDoc President& CEO. Based on this clearance, WellDoc will offer BlueStar and BlueStar Rx.
Jan. 20 WellDoc, a Columbia health care technology company, has received clearance from the U.S. Food and Drug Administration to sell a version of its diabetes management mobile application that does not require a prescription. The new offering, which should be available by the end of March, significantly expands WellDoc's potential client base a
WASHINGTON- Allergan plc announced the approval of RHOFADE cream by the U.S. Food and Drug Administration for the topical treatment of persistent facial erythema associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29.. RHOFADE will be available for commercial supply start
Allergan plc,, a leading global pharmaceutical company, announced today the approval of RHOFADE? cream by the U.S. Food and Drug Administration for the topical treatment of persistent facial erythema associated with rosacea in adults. "The FDA approval of RHOFADE? exemplifies Allergan's commitment to continuing to address unmet patient needs
CyMedica Orthopedics Inc has received FDA 510(k) clearance for e-vive, an app-controlled, data-driven muscle-activation and patient-engagement therapy designed to help patients prepare for, and then rehab after, ACL and TKR surgery.
THE Bank of Industry, BoI, has beckoned Small and Medium Enterprises operators whose products have met quality certification by National Agency for Food, Drug Administration and Control, NAFDAC, to come for loan to expand their operations and create employments. Recall that four years ago, specifically in 2014, BoI earmarked over N300 billion loan
That decision came just last week when Egalet' s ARYMO ER received FDA approval, marking the first approval for an Egalet product using the company's Guardian Technology, which has been called " best-in-class." Benzinga recently had the chance to speak with Egalet' s CEO Robert "Bob" Radie about the nuances of the FDA decision on ARYMO ER, and how
Release date- 18012017- London- Hikma Pharmaceuticals PLC,, the fast growing multinational pharmaceutical group, announces that its wholly owned US subsidiary, Roxane Laboratories, Inc., has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem. Roxane is curre
Multinational London-based pharmaceutical group Hikma Pharmaceuticals PLC's wholly owned US subsidiary Roxane Laboratories Inc has received an approval from the US Food and Drug Administration (FDA) for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem by Jazz Pharmaceuticals.
The U.S. Food and Drug Administration has approved IMBRUVICA for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. 1 Accelerated approval was granted for this indication based on overall response rate. IMBRUVICA is jointly developed and commercialize
FDA is also announcing that it has added a document to the docket for the public hearing entitled "Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products". The Memorandum provides additional background on the issues FDA is...
Obalon Therapeutics Inc., a vertically integrated medical technology company, announced today that they will be ringing the Nasdaq Stock Market closing bell, to recognize the recent launch of the Obalon Balloon System, the first and only FDA- approved swallowable, gas-filled intragastric balloon for weight loss. On September 8 th, Obalon recei
By a News Reporter-Staff News Editor at Women's Health Weekly Roche announced that it received clearance from U.S. Food and Drug Administration via Direct de novo decision on their Anti-Mullerian assay, making it the first approved fully automated AMH test available in the US to doctors looking to help women who are planning to become pregnant or