Search Results for “FDA” – Page 170 – media

Partner Therapeutics (PTx) Acquires Leukine® from Sanofi

Purchase includes Lynnwood, WA Biologics Manufacturing Facility
- Source: finance.yahoo
- 634
- April 4, 2018
acute myelogenous leukemia FDA Leukine Sanofi
UCB Announces Filing Acceptance with the China Food and Drug Administration for CIMZIA® (certolizumab pegol) for the Treatment of Moderate-to-Severe Rheumatoid Arthritis

UCB, a global biopharmaceutical company, announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of CIMZIA® (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA).
- Source: ucb
- 721
- April 3, 2018
CFDA CIMZIA® New Approvals RA
Procedures and Requirements of GMP Certification of Pharmaceutical Drugs in the Philippines

According to the latest data, the population of the Philippines has exceeded 100 million, and the demand for various types of medicine shows a steady increase. With the advancement of relations between China and the Philippines and collaborations in economy and trade, the Philippines has become a prime exporting country for Chinese pharmaceutical companies.
- Source: Ddu
- 2,089
- April 3, 2018
Ddu College Philippines
Device able to quickly and accurately detect stroke

A new visor-like device worn by patients can help providers and emergency medical personnel detect a stroke that requires comprehensive care within seconds and with greater than 90 percent accuracy.
- Source: Health Data Management
- 721
- April 3, 2018
FDA medical device New Approvals stroke
Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
- Source: Shire
- 608
- April 2, 2018
angioedema HAE lanadelumab New Approvals
Third Rock debuts immunometabolism startup Rheos with $60M launch round

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: pharmacompass
- 628
- March 30, 2018
financing immune Market Views
Alnylam Presents New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the 16th International Symposium on Amyloidosis

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the Company presented new results from the APOLLO Phase 3 study of patisiran, an investigational, RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis at the 16th International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan. In addition, the Company presented new data from the Phase 1 study of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis.
- Source: biospace
- 579
- March 30, 2018
ATTR amyloidosis Clinical Trials hereditary ATTR
Bigfoot brings in $55M Series B to propel integrated diabetes platform

This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
- Source: MedCityNews
- 788
- March 30, 2018
Company Insights diabetes FDA funding
Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: finance.yahoo
- 538
- March 29, 2018
HIV-1 New Approvals Symfi™
Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin®) For The Treatment Of Three Types Of Cancer

Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
- Source: finance.yahoo
- 604
- March 28, 2018
Allergan Amgen biosimilar herceptin New Approvals

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