VERTEX PHARMACEUTICALS INC: FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
Opportunity to treat the underlying cause of CF earlier than ever before
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SIMULATIONS PLUS, INC.: FDA Purchases Bundle of ADMET Predictor® Licenses
Center for Tobacco Products incorporates machine learning platform to assist toxicology research
CURRENT HEALTH: Receives FDA Clearance for its Remote Patient Monitoring Solution for In-Home Care, Demonstrates Reduced Hospital Readmissions
Company growth and customer adoption continues with hospitals and home healthcare agencies as the industry shifts to community-centric, value-based care
PHILLIPS-MEDISIZE: Expands FDA Compliant Medical Manufacturing Capacity to Support Growing Customer Needs
Phillips-Medisize, a Molex company, today announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA. The facility is FDA 21 CFR part 820 compliant.
Rising number of FDA advisory positions left unfilled
The number of vacancies on U.S. Food and Drug Administration advisory committees ticked upward during the final months of 2018, according to the agency’s most recent numbers.
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PURDUE PHARMA LP: FDA Grants Competitive Generic Therapy (CGT) Designation to Purdue Pharma’s Investigational Nalmefene HCl Injection for the Emergency Treatment of Known or Suspected Opioid Overdose
Committed to advancing solutions to the opioid addiction crisis, Purdue will not profit from nalmefene HCl
BELITE BIO, INC.: Announces FDA Approval of Investigational New Drug (IND) for Phase 1 Clinical Trial of LBS-008 to Treat Macular Degeneration and Stargardt Disease
Belite Bio, a drug development company targeting currently untreatable conditions in ophthalmology and metabolic diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for LBS-008 (BPN-14967), a first-in-class oral therapy for the treatment of atrophic Age-related Macular Degeneration (commonly known as dry AMD) and Stargardt disease, an inherited juvenile form of macular degeneration.
SYSTECH INTERNATIONAL: Optimal Solution team selected for FDA DSCSA Pilot Program
"The Optimal Solution" is a team of seasoned industry innovators cooperatively leveraging their expertise to demonstrate interoperability at scale in the pharma supply chain ecosystem. Team members include: RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk and CalQLogic.
Revamped FDA website to launch this week
Food and Drug Administration Acting Commissioner Ned Sharpless announced a new FDA.org website to launch this week.
Responsible innovation in dietary supplements to be discussed at FDA public meeting
As part of a continuing effort to modernize and reform the oversight of dietary supplements, the Food and Drug Administration announced a public meeting on May 16 from 8:30 a.m. to 4 p.m. to canvass ideas on facilitating responsible innovation.
ISOTHRIVE LLC: ISOThrive's Novel Microbiome-Inspired GERD Therapeutic Begins FDA Drug Approval Path
New Solution, Not Based on Acid Reduction, Found to Relieve Symptoms, Believed to Restore Localized Distal Esophageal Microbiome
U.S. FOOD AND DRUG ADMINISTRATION: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
As part of the U.S. Food and Drug Administration’s mission to protect the public health, outlined in our Medical Device Safety Action Plan, we are committed to continuing to strengthen and modernize how we take action to address device safety issues that emerge in the post-market in a more timely and effective way.
U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls
Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration.
Corey Polen battles for right to receive ALS medication
Corey Polen was a healthy 40-year-old man enjoying his life with his wife and three children. In October of 2015 that all changed when he started feeling spurts of weakness, not thinking too much about it until it began to progress rapidly with no answers.
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U.S. FOOD AND DRUG ADMINISTRATION: Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. I
CIRCASSIA PHARMACEUTICALS, INC.: US Food and Drug Administration Approves DUAKLIR® PRESSAIR® (aclidinium/formoterol) for Patients with Chronic Obstructive Pulmonary Disease (COPD)
Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced that the US Food and Drug Administration has approved DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
FDA could be prohibiting terminal patients from life-saving treatments and medication
The world of pharmaceuticals and biotechnology is ever-growing and changing, but seemingly only behind closed doors.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first generic naloxone nasal spray to treat opioid overdose
Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment
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FDA assesses duoenoscope contamination risk
The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.