Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing antibody-drug conjugates (ADCs) for cancer treatment, saw its shares leap by 23% following a robust third-quarter earnings report that surpassed Wall Street’s expectations. Investors and analysts alike have taken note, as Mersana Therapeutics’ financial results not only demonstrate strong revenue growth but also highlight strategic […]
Medtronic has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting approval for its Affera Mapping and Ablation System, including the Sphere-9 catheter. This approval, announced on 24 October 2024, positions Medtronic as the first and only company to offer dual-energy pulsed field ablation (PFA) and radiofrequency (RF) technologies for atrial […]
Indoco Remedies Limited has secured a significant regulatory win by receiving final approval from the United States Food and Drug Administration (USFDA) for its generic version of Cetirizine Hydrochloride Tablets USP, 10 mg. The approval allows Indoco Remedies to market its product in the U.S. as a direct competitor to Johnson & Johnson Consumer Inc.’s […]
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s RYBREVANT (amivantamab-vmjw) in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that features epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations. This approval targets patients whose disease has […]
Johnson & Johnson is set to pay an additional $1.1 billion to settle tens of thousands of lawsuits claiming its baby powder and other talc-based products caused cancer. This increase brings the total settlement amount to over $9 billion, marking a significant development in the years-long legal battle over allegations that the company’s talc products […]
Johnson & Johnson (NYSE: JNJ) has made headlines with its decision to acquire V-Wave Ltd., a private company renowned for its cutting-edge treatments for heart failure. The agreement, valued at an upfront payment of $600 million and potential additional payments totaling approximately $1.1 billion, marks a strategic expansion for Johnson & Johnson MedTech. This acquisition […]
The U.S. Food and Drug Administration (FDA) has approved the combination of RYBREVANT (amivantamab-vmjw) and LAZCLUZE (lazertinib) as a first-line therapy for adults with advanced non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) mutations. This approval marks a significant advancement in the treatment landscape for patients with EGFR-mutated NSCLC, providing a […]
Johnson & Johnson (NYSE: JNJ) is seeking U.S. Food and Drug Administration (FDA) approval for SPRAVATO (esketamine) as a standalone treatment for adults with treatment-resistant depression (TRD). This application marks a significant milestone in the treatment of major depressive disorder (MDD). The American pharma major has submitted a supplemental New Drug Application (sNDA) to the […]
Johnson & Johnson (NYSE: JNJ) has successfully concluded its acquisition of Yellow Jersey, a division previously part of Numab Therapeutics, for a substantial $1.25 billion. This strategic move secures Johnson & Johnson the exclusive global rights to NM26, a pioneering bispecific antibody set to advance into Phase 2 trials for treating atopic dermatitis (AD). NM26 […]
In a significant development for the treatment of drug-resistant tuberculosis (TB), Johnson & Johnson has announced that SIRTURO (bedaquiline) has received full approval from the U.S. Food and Drug Administration (FDA) and the European Commission (EC). This approval marks a pivotal milestone in the fight against pulmonary TB that is resistant to standard treatments like […]
