FDA in Medical Technology

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

TITUSVILLE, N.J., Aug. 3 /PRNewswire/ -- The U.S. Food and Drug Administration approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults on Friday, July 31, 2009. It is the first ...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR ) and King Pharmaceuticals, Inc. (NYSE: KG ) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response ...

Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

Adaptive trials leader and CDRH regulators join to create Bayesian trial design and analysis software standard CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Cytel Inc., a leading provider of biostatistical software and clinical trial design services, today announced the signing of a Cooperative...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

Safety and Biologic Activity Data Reviewed in End of Phase 2a Meeting SAN FRANCISCO, June 11 /PRNewswire-FirstCall/ -- VIA Pharmaceuticals, Inc. (Nasdaq: VIAP ), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, annou...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

MONTEREY, Calif., June 2 /PRNewswire/ -- This month's Journal of Aerosol Medicine and Pulmonary Drug Delivery features positive Phase Ib clinical trial results for PARI Pharma's L-CsA, inhaled liposomal cyclosporine A. In May, PARI Pharma received Orphan Drug Designation from the Food and Drug Ad...

NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia

Potential Seven Years Market Exclusivity in PHN Pending Product Approval SAN MATEO, Calif., June 2 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the Offic...

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)

- First-in-class treatment for inhalation anthrax - ROCKVILLE, Md., May 21 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its human monoclona...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer). ...

Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles

Ellman International launches next-generation aesthetic skin tightening technology OCEANSIDE, N.Y., May 18 /PRNewswire/ -- Ellman International, Inc. announced today that the Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the non-ablative...

U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold

CAMBRIDGE, Mass., May 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR ) announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure's oxygen therapeutic Hemopur...

D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients

REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate ...

Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth

- Study provides clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia in males commonly known as 'male pattern baldness' - BOCA RATON, Fla., April 20 /PRNewswire/ -- Findings of the pivotal clinical trial of the HairMax LaserComb that provided clear evidence ...

Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA

UPPSALA, Sweden, April 14 /PRNewswire-FirstCall/ -- Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize dru...

Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes

SILVER SPRING, Md., April 2 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has finalized its discussions of questions related to liraglutide, a once-daily human GLP-1 anal...

Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.

Company Expands Overseas TBI Trial COSTA MESA, Calif., March 19 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received a letter from the FDA that outlines what the agency termed a "path forward" as a basis to resume clin...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

TITUSVILLE, N.J., Feb. 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for...

Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

Journal of American College of Cardiology publishes positive ATLAS clinical data NATICK, Mass., Feb. 5 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final modules of the Company's...

Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis

CPF Calls on Manufacturer and FDA to Expedite Review of Pirfenidone as Treatment for PF SAN JOSE, Calif., Feb. 4 /PRNewswire-USNewswire/ -- The Coalition for Pulmonary Fibrosis (CPF) is calling this a historic time in the research and treatment of PF, as a pivotal Phase III clinical trial is ...

Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission

SEATTLE, Jan. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics (CTI) (Nasdaq and MTA: CTIC) announced today that after communication with the Food and Drug Administration (FDA), CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to ...

U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

Schering-Plough expects to respond to agency during first quarter KENILWORTH, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (asenapine) s...

Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication

SOUTH SAN FRANCISCO, Jan. 9 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV ) today announced that the U.S. Food and Drug Administration (FDA) has approved Anesiva's supplemental New Drug Application (sNDA) to expand the indication for Zingo(TM) to treat the pain associated with blood ...

AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)

LONDON, Dec. 11 /PRNewswire-FirstCall/ -- On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - ...

Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the U.S. Food and Drug Administration (FDA) recently indicated that the ongoing ext...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)

NUTLEY, N.J., Dec. 4 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for ACTEMRA(R) (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal anti...

Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings

EMERYVILLE, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI ) today announced that the FDA has reviewed the company's manufacturing and control process descriptions (CMC), and has provided guidance on how Bionovo can move forward with the development of Menerba (formerly nam...

PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.

Study Expanded to 406 Subjects FRANKLIN, Mass., Nov. 26 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced today that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the C...

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

DEERFIELD, Ill., and OSAKA, Japan, Nov. 24 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recomm...

Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen

ABBOTT PARK, Ill., Oct. 20 /PRNewswire-FirstCall/ -- Abbott has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a controlled-release form of hydrocodone with acetaminophen. Abbott is evaluating the FDA Complete Respons...

Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008

REINACH, Switzerland, October 14 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous ...

Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data

- Company Plans to Announce Interim Results in January 2009 and Final Trial Data in mid-2009 - EMERYVILLE, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII ) today announced that following a meeting with the U.S. Food ...

Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval

SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure....

Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration of Voice Loss

Milestone Marks Company's Entrance into the Injectable Filler Market PALO ALTO, Calif., Sept. 21 /PRNewswire/ -- Coapt Systems Inc. today announced the launch of its Novielle Voice family of injectable fillers at the 112th annual meeting of the American Academy of Otolaryngology -- Head and ...

Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040

MONTREAL, Sept. 19 /PRNewswire/ -- Enobia Pharma, an emerging biotech company focused on developing novel therapeutics for serious bone disorders, announced that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for ENB-0040, its enzyme replacement therap...

REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX ) announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candida...

Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

BRIDGEWATER, N.J., Aug. 8 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq(R) (dronedarone). The priority review period begins on...

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease

Agency Supports Amigal Move to Phase 3; Eligible for Accelerated Approval; Final Global Regulatory Plan Expected by Year End CRANBURY, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD ), a biopharmaceutical company developing small molecule, orally-administere...

U.S. FDA Issues Action Letter for Sugammadex

KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia. ...

Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer

SEATTLE, July 23 /PRNewswire/ -- Sound Pharmaceuticals (SPI) has filed an Investigational New Drug Application with the FDA for the clinical testing of a proprietary formulation of ebselen for the prevention of chemotherapy induced hearing loss or ototoxicity. The oral capsule containing ebsel...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

September meeting to focus on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma SEATTLE, July 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced toda...