FDA – Page 15 – media

Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo

Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. In the U.S., impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.
- Source: drugs
- 656
- December 18, 2017
FDA impetigo New Approvals skin problems Xepi (ozenoxacin) Cream
FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
- Source: massdevice
- 568
- December 14, 2017
FDA interoperable medical device Policy
FDA Announces 3 New Digital Health Policy Changes

FDA Commissioner Scott Gottlieb, MD, today announced 3 policy changes meant to encourage digital health innovation while modernizing the agency’s oversight of new tech.
- Source: hcanews
- 1,289
- December 8, 2017
digital health FDA innovation Policy
FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
- Source: Gene
- 559
- December 8, 2017
FDA Genentech New Approvals Roche
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 OZEMPIC® is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.
- Source: medicalxpress
- 575
- December 6, 2017
diabetes FDA Novo Nordisk OZEMPIC®
FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration (FDA) today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.
- Source: mdlinx
- 628
- December 5, 2017
breast cancer FDA herceptin New Approvals Ogivri stomach cancer
Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.
- Source: raps.org
- 686
- December 4, 2017
cancer FDA NIH Policy
Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority

Review Designation of Mogamulizumab’s Biologics License Application
- Source: drugdu
- 482
- November 29, 2017
Biologics License Application FDA New Approvals
Allegoric Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia

Allergan plc (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLAR™ (cariprazine) for the maintenance treatment of adults with schizophrenia. VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
- Source: Allergan
- 474
- November 24, 2017
bipolar I disorder FDA schizophrenia VRAYLAR™
Pfizer and Genentech Duke it Out in Court Over Herceptin Biosimilar Patents

On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.
- Source: Biospace
- 644
- November 24, 2017
biosimilar Company Insight FDA Genentech herceptin Pfizer Roche

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