Search Results for “FDA” – Page 64 – media

FDA refuses to review Alkermes’ depression drug, demands additional clinical trials

The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.
- Source: fiercebiotech
- 695
- April 6, 2018
ALKS 5461 Depression New Approvals
Martin Pharmaceuticals Receives FDA Orphan Drug Designation For LIVANTRA™

MARTIN PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR LIVANTRA™
- Source: martinpharma
- 612
- April 4, 2018
FDA LIVANTRA™ rare (orphan) diseases
Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA® (perampanel) Pediatric Indications

Eisai Inc. announced that it has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for its antiepileptic drug FYCOMPA® (perampanel) CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years). The submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 to less than 12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.
- Source: prnewswire
- 642
- April 4, 2018
Eisai FDA FYCOMPA® New Approvals
Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.
- Source: drugs
- 563
- April 3, 2018
bremelanotide FDA New Approvals
FDA to expand digital health pre-cert program by end of 2018

The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.
- Source: Beckers Hospital Review
- 655
- April 2, 2018
digital health FDA medical device Policies
FDA clears Medtronic’s smartphone-connected CGM for MDI users

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
- Source: mobihealthnews
- 810
- March 30, 2018
FDA Guardian Connect insulin Medtronic New Approvals
Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
- Source: Novartis
- 625
- March 29, 2018
FDA New Approvals Ph+ CML-CP Tasigna®
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
- Source: drugdu
- 582
- March 29, 2018
FDA MBS New Approvals Opdivo
FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
- Source: MedCityNews
- 700
- March 29, 2018
diabetes FDA insulin New Approvals
Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
- Source: novartis
- 625
- March 26, 2018
chronic myeloid leukemia Clinical Trials FDA Tasigna®

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