Resources
BNET Resources
- sort by:
- Relevance
- Date
- Popularity
- ProEthic Pharmaceuticals Announces Acceptance of New Drug Application for Migraine
- MONTGOMERY, Ala. -- ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses and markets niche prescription products, announced today that the U.S. Food and Drug Administration FDA has accepted the Company's submission of its New Drug Application for PRO-513 for the treatment of migraine headaches. In...
- Research articles 2007-12-12
- FDA Recommending RFID-Based Solutions to Help the Pharmaceutical Industry Combat Counterfeit Drugs, IDC Finds
- FRAMINGHAM, Mass. -- The manufacturing and importation of counterfeit drugs represents a particularly problematic issue in the United States - for patients as well as the pharmaceutical industry. To protect the efficacy of the drug manufacturing and distribution process and to ensure research and development costs are fully recovered through...
- Research articles 2004-08-02
- FDA Extends Review of EPIX Pharmaceuticals' Appeal of Vasovist™ Approvable Letters
- CAMBRIDGE, Mass. -- EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging MRI which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that the U.S. Food and Drug Administration FDA has advised EPIX that it is extending its review...
- Research articles 2006-07-28
- FDA to revamp cGMP guidelines to adopt risk-based approach. (Pharmaceuticals & Fine Chemicals).(US Food and Drug Administration current good manufacturing practices)(Brief Article)
- THE FOOD and Drug Administration FDA plans to introduce sweeping reforms over the next several years to the way pharmaceutical quality systems and current good manufacturing practices cGMP are regulated. The move comes as the agency finds its r THE FOOD and Drug Administration...
- Research articles 2002-09-02
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist™ Approvable Letters; Company Remains Committed To Making Novel Blood-Pool Imaging Agent Available in U.S
- CAMBRIDGE, Mass. -- EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging MRI which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that it has submitted a formal appeal to the U.S. Food and Drug Administration FDA asking the...
- Research articles 2006-06-30
- Novagali Pharma Receives US FDA Orphan Drug Designation for Vekacia(R) for the Treatment of Vernal Keratoconjunctivitis.
- EVRY, France, May 25 /PRNewswire/ -- Novagali Pharma, an emerging ophthalmic pharmaceutical company, announced today orphan drug designation granted by the U.S. Food and Drug Administration FDA to Cyclosporine A drug VekaciaR, a patented cati EVRY, France, May 25 /PRNewswire/ -- ...
- Research articles 2007-05-25
- GW Pharmaceuticals' smoking gun.
- Shares in GW Pharmaceuticals rose 10 per cent despite the refusal by the US Food and Drug Administration FDA to accept that smoking cannabis has any medical effects. Shares in GW Pharmaceuticals rose 10 per cent despite the refusal by the US Food and...
- Research articles 2006-04-28
- FDA to consolidate pharmaceutical product reviews
- The Food and Drug Administration has announced the consolidation of the agency's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation and Research. Work currently performed by the FDA's Center for Biologics EvaluatiThe Food and Drug Administration has announced the consolidation of the agency's responsibility for reviewing...
- Research articles 2002-11-01
- Astellas Pharma Submits NDA for FK506 Immunosuppressant to FDA
- Tokyo, Dec 26, 2005 - JCN - Astellas Pharma announced on December 26 that its US subsidiary Astellas Pharma US has filed a New Drug Application for FK506 modified release formulation tacrolimus, its proprietary immunosuppressant, with the US Food and Drug Administration FDA.
- Research articles 2005-12-26
- Victory: F.A.N.S. Helps Generate Nearly 40,000 Responses Rejecting Wyeth's Attempt at Back-Door Ban of Bio-Identical Hormones
- WASHINGTON, April 11 /U.S. Newswire/ -- "The FDA has certainly never seen a public response like the one that is currently being launched by concerned citizens who want their medical freedom protected from a possible monopoly by pharmaceutical companWASHINGTON, April 11 /U.S. Newswire/ -- "The FDA has certainly never seen...
- Research articles 2006-04-11
- Collegium Pharmaceutical Inc. Announces FDA Acceptance of IND for its Abuse Deterrent Sustained Release Opioid Product
- CUMBERLAND, R.I. -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the Investigational New Drug Application ("IND") for its patent pending, abuse deterrent, sustained release, oral opioid formulation COL-003 is now active following its acceptance by the U.S. Food and Drug Administration FDA. The Company submitted the IND...
- Research articles 2007-07-12
- Shire pharma faces early challenge.
- Shire Pharmaceuticals' attention-deficit drug Adderall XR could face generic competition as early as 2006, despite its approval this week by the US Food and Drug Administration FDA for adult use. Shire Pharmaceuticals' attention-deficit drug Adderall XR could face generic competition as early as 2006,...
- Research articles 2004-08-20
- Collegium Pharmaceutical Inc., Announces the Filing of IND for Abuse Deterrent Sustained Release Opioid Product
- CUMBERLAND, R.I. -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has filed an Investigational New Drug ("IND") for its patent pending abuse deterrent sustained release opioid formulation COL-003. This follows a pre-IND meeting that the Company held with the FDA in March 2007 at which time...
- Research articles 2007-06-15
- FDA acts against generic digoxin
- Based on a D.C. federal court settlement, the FDA is formally proposing to revoke a 1974 special digoxin regulation that had allowed generic digoxin tablets to remain on the market without agency approval of their safety and effectiveness, and to require submission of marketing applications. Brought against the FDA by...
- Research articles 2001-02-01
- SHIRE PHARMA. (SHP).
- Shire Pharmaceuticals has called on US regulators to carry out further investigations into the link between attention deficit hyperactivity disorder ADHD drugs and heart problems. The US Food and Drug Administration's FDA advisory committee recen Shire Pharmaceuticals has called on US regulators to carry out ...
- Research articles 2006-02-17
- FDA Accelerates Its Approval of New Drugs.(Brief Article)
- THE FOOD AND DRUG Administration's Center for Drug Evaluation and Research reviewed 199 new drug applications in 1998 and approved 90 of them, according to an FDA performance report. The average review time by the FDA department in 1998 was 12 ...
- Research articles 1999-02-15
- Challenge to Pediatric Drug Rule Rejected.
- FDA and brand-name pharma industry score a victory over generic manufacturers. A FEDERAL COURT has denied the generic drug industry's request for an injunction to stop the Food and Drug Administration's program to promote research on the safe ...
- Research articles 1999-05-03
- FDA wants reform of medical device ads.(Capital Watch)(Food and Drug Administration)(Brief Article)
- Hearing aids and other medical devices may fail under the same broadcast advertising standards as pharmaceuticals. Under a proposal by the Food and Drug Administration, advertisers would be encouraged to disclose the most serious and common risks a Hearing aids and other medical devices...
- Research articles 2004-02-16
- Helsinn and MGI Pharma Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA.
- LUGANO, Switzerland, January 3 /PRNewswire/ -- Helsinn Healthcare S.A., Switzerland, a privately owned pharmaceutical group and its partner, MGI Pharma (Nasdaq: MOGN), a biopharmaceutical company focused in oncology and acute care, today announ LUGANO, Switzerland, January 3 /PRNewswire/ -- ...
- Research articles 2008-01-03
- Gloucester Pharmaceuticals Receives Special Protocol Assessment for Pivotal Phase II Trial of Romidepsin in Patients with Peripheral T-Cell Lymphoma
- CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused specialty pharmaceutical company, announced today that it has reached an agreement with the U.S. Food and Drug Administration FDA under the FDA's Special Protocol Assessment SPA process for the design of its planned pivotal trial of romidepsin in patients with peripheral...
- Research articles 2007-01-30
- << Previous
- page 1 of 8
- Next >>
Refining Tags
- Government (27 results)
- Federal Government (26 results)
- Manufacturing (13 results)
- agency (8 results)
- PhRMA (7 results)
- Software (7 results)
- Biotechnology (6 results)
- Health Care (6 results)
- Advertisement (6 results)
- patient (6 results)
- Jim Edwards (5 results)
- R&D (4 results)
- Drug Company (4 results)
- U.S. Congress (4 results)
- sales (4 results)
- Standards (4 results)
- stock (3 results)
- RFID (3 results)
- manufacturer (3 results)
- U.S. Senate (3 results)
- Analysis (3 results)
- John Maas (3 results)
- Pivotal Corp. (3 results)
Presented by American Express