FDA Grants 510(k) Clearance for Respinova’s Pulsehaler
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...
Passage Bio’s Treatment for Krabbe Disease is Granted Orphan Designation by EMA
The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
European Commission Plans for Revision of Pharmaceutical Legislation
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is "intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant"...
LATAM Series: Brazil’s Medical Device Regulatory Pathway
Latin America (LATAM) is a diverse region, with over 650 million people spread across 20 different countries, each with their own culture and unique history. For medical device companies, LATAM is a promising market, with its current value estimated to be $11 billion...
FDA Approves Two New Treatments for High Blood Pressure and Cancer
The U.S. Food and Drug Administration (FDA) approved of two treatments to treat high blood pressure (pulmonary hypertension) and cancer (multiple myeloma). United Therapeutics won approval for Tyvaso (treprostinil) Inhalation Solution, its pulmonary hypertension...
FDA Grants Breakthrough Device Designation for Premia Spine’s TOPS™ Spinal Arthroplasty System
The U.S. Food and Drug Administration (FDA) granted Premia Spine's TOPS™ Spinal Arthroplasty System Breakthrough Device Designation to treat patients diagnosed with spinal stenosis and spondylolisthesis. The approval marks the first ever joint replacement system for...
FDA Provides New & Revised Product-Specific Guidances
The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA's expectations in regards to clinical studies demonstrating bioequivalence...
First-Ever Valve Approved by FDA for Congenital Heart Disease
The U.S. Food and Drug Administration (FDA) approved of the first-ever valve for treating pulmonary valve regurgitation in patients with certain kinds of congenital heart disease. The device, called Harmony Transcatheter Pulmonary Valve (TPV) has been granted...
Takeda’s Dengue Vaccine Begins Regulatory Submissions
Takeda's dengue vaccine candidate's filing packages has been accepted by the European Medicines Agency (EMA), which is being investigated for its prevention of dengue in individuals between the ages of 4 and 60. Takeda also submitted the vaccine for regulatory...
LetsGetChecked’s COVID-19 At-Home Test Approved by FDA
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked's COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...
Merck Granted Label Expansion by FDA for Keytruda
Keytruda, Merck's checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or esophageal...
FDA Grants EUA to Beckman Coulter’s COVID-19 Antibody Test
The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to a COVID-19 antibody test created by Beckman Coulter. The antibody test measures the level of antibodies in a patient in response to COVID-19 to provide both a qualitative as well...
Study Shows AstraZeneca Vaccine Ineffective Against South African Variant
The New England Journal of Medicine published results from a study to test AstraZeneca's vaccine's efficacy for the South African variant of COVID-19. The clinical study was conducted in South Africa with 1,467 participants, of which 2.5% developed mild-to-moderate...
FDA Provides Smooth Pathway for COVID-19 Screening Tests
The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...
EMA Offers Guidance on Labeling for COVID-19 Therapeutics
The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product's...
E-Labeling for the Life Sciences Industry
There has been a drastic increase in regulations surrounding labeling for medical devices over the past decade. As our world shifts towards a more digital landscape, e-labeling, which is an electronic version of an Instruction for Use (IFU), has become more popular...
FDA Grants Approval for Medtronic’s Labeling of Intellis™ Platform
The U.S. Food and Drug Administration (FDA) granted approval for revised commercial labeling of Medtronic's Intellis™ Platform with Differential Target Multiplexed (DTM™). The platform is meant to treat chronic and intractable leg and back pain. Charlie Covert, VP and...
Melinta Therapeutics’ Antibiotic Approved by FDA for Serious Skin Infections
The U.S. Food and Drug Administration (FDA) approved of Melinta Therapeutics' antibiotic Kimyrsa (oritavancin) for adults diagnosed with acute bacterial skin and skin structure infections (ABSSSI). Caused by susceptible isolates of designated Gram-positive...
PTC Announces Results of Real-World Study
PTC Therapeutics announced today the results of its real-world study for patients diagnosed with Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) who switched between prednisone to EMFLAZA® (deflazacort) after the U.S. Food and Drug...
FDA Clears Baxter’s AK 98 Hemodialysis Machine
Baxter International announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Artifical Kidney 98 (AK 98) dialysis machine. The next-gen, easy-to-use, portable machine is designed to administer hemodialysis (HD) treatments. Gavin...