The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Augtyro™ (repotrectinib) for treating adult and pediatric patients (12 years and older) with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This includes locally…
Today, the U.S. Food and Drug Administration (FDA) approved BLINCYTO® (blinatumomab) for treating adult and pediatric patients (one month or older) with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease…
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration (FDA) to enhance glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. This approval follows positive results from the pediatric T2NOW Phase…
Roche announced that the U.S. FDA has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This automated multiplex real-time PCR assay on the cobas® liat system delivers results in just 20…
GSK plc announced today that the US Food and Drug Administration (FDA) has given the green light to AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults aged 50 through…
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted approval for AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) to prevent RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 who…
MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage enterprise dedicated to developing telomere-targeting immunotherapies for cancer, has celebrated the validation of clinical and regulatory pathways for effective therapies leveraging the cell’s telomeric functions. This validation was underscored by the U.S.…
BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient. Ac-225 is an alpha-emitting isotope utilized in targeted alpha therapies (TATs), which…
Since its founding in 1886, Johnson & Johnson has been dedicated to addressing major health challenges and promoting a healthier world. Today, the company released its 2023 Health for Humanity Report, highlighting its progress in environmental, social, and governance (ESG)…
Today, Astellas announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Biologics License Application (BLA) for zolbetuximab, a groundbreaking investigational monoclonal antibody targeting claudin (CLDN) 18.2. This resubmission is intended for the first-line treatment…
Today, Pfizer released extended findings from the Phase 3 CROWN trial, examining the efficacy of LORBRENA® (lorlatinib), a third-generation ALK inhibitor, versus XALKORI® (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer (NSCLC). Following a median follow-up…
The U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior…