TGA Approves Global Sarcoma Therapy
The Therapeutic Goods Administration (TGA) has approved the use of Global Sarcoma Therapy called YONDELISÒ, marketed by Specialised Therapeutics, for Australian patients afflicted with "unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior...
India Sets New World Record of COVID-19 Cases
India recorded today the highest number of COVID-19 cases in a day today (4/22) at 314,835 infections, surpassing the previous record from the United States at 297,430. The exponential rise in cases have caused fear regarding hospital oxygen supply levels to treat...
Pipeline™ Flex Embolization Device with Shield Technology™ Receives FDA Approval
The U.S. Food and Drug Administration (FDA) granted Medtronic's Pipeline™ Flex Embolization Device with Shield Technology™ regulatory approval. The Shield Technology is designed to introduce the first surface-modified implant device that reduces the tendency of the...
FDA Grants Breakthrough Designation to Amgen’s Cancer Antibody Drug
The U.S. Food and Drug Administration (FDA) awarded Amgen's cancer antibody drug, bemarituzumab, Breakthrough Therapy Designation for a first-line treatment for specific kinds of gastric cancer. The decision comes after the FDA reviewed data from Phase II FIGHT study...
New Oral Contraceptive Called NEXTSTELLIS Approved by FDA
NEXTSTELLIS, the first and only oral contraceptive pill containing E4, has been approved by the U.S. Food and Drug Administration (FDA). E4 is a naturally occurring estrogen that is now being produced from a plant source, and differs from other estrogens as a Native...
FDA’s ACIP Requires More Data for J&J COVID-19 Vaccine Decision
The U.S. Food and Drug Administration's (FDA) Advisory Committee on Immunization Practices (ACIP) met on April 14 to provide its recommendation regarding the pause of the Johnson & Johnson COVID-19 vaccine due to the association of extremely rare but potentially...
The Importance of Patient Diversity: Asian Americans and Diabetes
Patient centricity and patient diversity are two trends that have taken the life science sector by storm. Simply put, patient centricity is defined as “designing a treatment, clinical trial, or other health solution centered around the patient”. Patient diversity, on...
Illuminare-1 Granted IND Approval by FDA for First-In-Human Trial
The U.S. Food and Drug Administration (FDA) granted Illuminare-1 Investigational New Drug (IND) approval for the first-in-human trial at Memorial Sloan Kettering Cancer Center (MSK). Illuminare-1 is a small molecule, myelin binding agent that is meant to improve the...
FDA Grants Second Approval for Gilead’s Trodelvy
The U.S. Food and Drug Administration (FDA) granted accelerated approval for Trodelvy, a drug therapy for patients with locally advanced or metastatic urothelial cancer (mUC), an aggressive disease with a survival rate of 5.5%. Previously, Trodelvy was granted...
FDA Approves of Revolutionary AI Device for Colonoscopy
The U.S. Food and Drug Administration (FDA) announced de novo clearance of GI Genius™, a revolutionary AI device for colonoscopy. The device is the first of its kind, and was developed by Cosmo Pharmaceuticals, with exclusive distribution rights to Medtronic....
FDA Announces Closer to Zero Plan to Reduce Toxic Elements from Baby Food
The U.S. Food and Drug Administration (FDA) announced today an actionable plan, called Closer to Zero, to reduce the exposure of toxic elements in foods commonly consumed by babies and young children. While FDA's testing results have shown that there is no immediate...
Donisi De Novo Granted FDA Clearance for Contact-Free Multiparameter Measurement System
The U.S. Food and Drug Administration (FDA) has granted Donisi De Novo clearance for its contact-free multiparameter measurement system. The innovative system is backed by 26 patents and consists of a combination of artificial intelligence (AI), algorithms, and...
Eli Lilly and Incyte’s Atopic Dermatitis Drug Receives Extended Supplemental NDA Review
Eli Lilly and Incyte's atopic dermatitis drug received extended supplemental New Drug Application (NDA) review by the U.S. Food and Drug Administration (FDA) for baricitinib, a drug therapy intended for patients with moderate-to-severe conditions. The extension came...
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...