The European Union (EU) has AstraZeneca’s Tagrisso for the treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer...
FDA recently approved Amgen’s Lumakras, the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation and who have received at least...
FDA recently approved Janssen’s Rybrevant as the first targeted therapy for patients with subset of non-small cell lung cancer.
The agency approved the therapy based on a study of 81...
Pfizer and BioNTech recently announced the initiation of a Biologics License Application for full FDA approval of their mRNA COVID-19 vaccine
With the application, the companies submitted data t from...
FDA recently approved Opdivo, making it the first immunotherapy for initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal...
AstraZeneca recently announced that China approved its prescription drug, Tagrisso, for the treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung...
FDA recently authorized marketing of the GI Genius, a medical device that uses artificial intelligence (AI) to assist clinicians in detecting signs of colon cancer.
GI Genius is based on machine...
FDA recently approved Abecma, the first cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after previous...
FDA recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) COVID-19 diagnostic test.
BioFire RP2.1 is used for the simultaneous qualitative detection of multiple...
FDA recently approved G1 Therapeutics’ Cosela a therapy intended to reduce the frequency of chemotherapy-induced bone marrow suppression in adults for extensive-stage small-cell lung...
FDA recently approved Bristol Meyer Squibb’s CAR-T cell therapy Breyanzi for the treatment of certain types of large B-cell lymphoma in patients who have not responded to previous treatment...
FDA recently issued an emergency use authorization to Eli Lilly & Company for its combination COVID-19 antibody treatment.
The authorization states that providers can administer the...
FDA recently approved the first generic drug for the treatment of severe hypoglycemia, which may occur in patients with diabetes mellitus.
Amphastar Pharmaceutical’s generic of glucagon...
GSK recently announced that FDA approved BENLYSTA (belimumab) as the first chronic disease treatment for adult patients with lupus nephritis (LN), who are receiving standard...
Roche recently announced that its COVID-19 antibody test, Elecsys, received FDA emergency use authorization.
Elecsys Anti-SARS-CoV-2 S measures the level of antibodies to the spike protein of...
Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary emergency use authorization to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.
This is the...
FDA recently approved Alnylam Pharmaceutical’s rare disease drug Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1 (PH1).
Oxlumo is now the first approved targeted...
FDA recently issued an emergency use authorization for Eli Lilly & Company’s COVID-19 antibody treatment for use in mild to moderate coronavirus in adults and pediatric patients.
The...
FDA recently approved Verklury as the first COVID-19 treatment. The approval signs off on using the drug also known as remdesivir has been signed in adults and pediatric patients 12 years of age or...
Today, CMS issued a proposed rule that would create a new, accelerated Medicare coverage process for innovative products that FDA deems “breakthrough,” including new implants or gene-based...
