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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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
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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.
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
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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).
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
U.S. FOOD AND DRUG ADMINISTRATION: Stockert/Sorin HeaterCooler System 3T
Class 2 Device Recall Stockert/Sorin HeaterCooler System 3T
U.S. FOOD AND DRUG ADMINISTRATION: Micro Knife 5.0mm 30
Class 3 Device Recall Micro Knife 5.0mm 30
U.S. FOOD AND DRUG ADMINISTRATION: o_two e700 Automatic Transport Ventilator
Class 1 Device Recall o_two e700 Automatic Transport Ventilator
U.S. FOOD AND DRUG ADMINISTRATION: Biomet RingLoc Hip System SelfTapping Bone Screw
Class 2 Device Recall Biomet RingLoc Hip System SelfTapping Bone Screw
BAYER HEALTHCARE LLC: Aleve PM NDA #205352
Aleve PM is the first and only over-the-counter (OTC) PM product with the 12-hour pain-relieving strength of Aleve plus a sleep aid. Each caplet combines the sleep aid diphenhydramine HCl (25 mg) with the pain reliever naproxen sodium (220 mg), a nonsteroidal anti-inflammatory drug, to provide relief from occasional sleeplessness associated with minor aches and pains. It can help you fall asleep and stay asleep.
SUN PHARMACEUTICAL INDUSTRIES LTD.: Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S.
INFUGEM™ (gemcitabine in sodium chloride injection) is the first and only chemotherapy product in a premixed, ready-to-infuse formulation
FDA gives clearance for Scientific Analytics and Hospital for Special Surgery for computer-vision collaboration
The FDA gave 510(k) medical device designation to Scientific Analytics (SAI) for DARI Health, a computer-vision-powered motion analysis technology.
Three-minute 'Theta Burst' treatment cleared by FDA
The FDA has cleared a new treatment for major depressive disorder.
FDA OK'd 272 drugs in March
The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.