Our advantages and services that will satisfy you:
News
February 16, 2018，The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).
“This is the first treatment approved for stage III unresec…
On February 14, 2018, the Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).
Approval was based on a multicenter, double-blind, clinical trial (SPARTAN, NCT01946204) randomizing 1,207 patients with NM-CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination wi…
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electroni…
The particular Indian pharmaceutical industry, which can be dependent on China for key intermediates and lively pharmaceutical ingredients (APIs), offers started feeling the ripple effects of a newly released arrêt of manufacturing units inside China over environmental issues.
Supply disruptions are probably across therapies, according to be able to industry experts, while a couple of people awar…
Biocon Ltd is betting on its biosimilars and research and development (R&D) services business to raise growth, a top exec at the firm said. Bengaluru-based Biocon is expecting substantial growth in 2018-19, after reporting a minor within net profit in the March quarter.
“The muted FY18 performance was due to continued pricing difficulties in the generics business, in conjunction with a planne…
Fresh Delhi: In a bid to reduce India’s dependence on China for active pharmaceutical ingredients (APIs), the chemicals and fertilizers ministry has joined hands to ministries to draw up a road map for increasing their production in the country.
Bulk drugs or APIs are the active raw materials used in medicines to offer them their therapeutic effect.
A high-level task force has been constituted…
CDRH’s vision for medical device safety to protect patients and spur innovation of new products that are safer, more beneficial, and deal with unmet medical needs.
Graphic of Medical Device Safety Action Plan: Protecting Sufferers, Promoting Public Health cover. The cover includes the U. S. Food and Drug Administration logo and an image of a patient and doctor. The patient is a young White girl l…
Typically the opioid epidemic is a single of the most deep public health crises going through the United States plus the current crisis regarding opioid overdose deaths demands revolutionary approaches. The organization has already taken important steps to decrease public experience of opioids, prevent brand new cases of opioid make use of disorder—also known as opioid addiction—and support the re…
The U. S. Food and Drug Administration (FDA) is warning that signs of a life-threatening side impact called differentiation syndrome are not being recognized in patients getting the severe myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Treatment Guide already contain a warning about differentiation problem. However, we have identify cases of different…
The foodstuff and Drug Administration, Centre for Drug Evaluation and Research and Small Enterprise and Industry Assistance (CDER SBIA), welcomes you to our webinar series.
These types of events concentrate on a specific topic and provide the opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The training calls support CDER SBIA’s mission o…
The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing i…
Typically the U. S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in afflicted patients. This can be the first FDA approval of any treatment for LEMS.
“There has been…