GSK's new shingles jab submitted for review by US regulator
GSK PLC (LSE:GSK, NYSE:GSK) has announced that the US Food and Drug Administration (FDA) is reviewing its new prefilled syringe version of Shingrix, its shingles vaccine. If approved, the updated delivery method would simplify vaccine administration by eliminating the need to mix separate components before use.
GSK swooping to buy US biotech IDRx for $1bn - report
UK pharma giant GSK PLC is close to buying US biotech startup IDRx for $1 billion to boost its cancer drug business, the Financial Times has reported. Backed by a raft of venture capital and private equity firms, the Plymouth, Massachusetts-based firm has been developing a treatment for gastrointestinal tumours.
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said on Tuesday.
GSK's ADC Drug Gets FDA's Breakthrough Tag for Rare Bone Cancer
The FDA bestows a Breakthrough Therapy designation to GSK's antibody-drug conjugate, GSK5764227, for treating relapsed or refractory osteosarcoma.
GSK's experimental cancer drug wins receives support from US regulator
GSK PLC (LSE:GSK, NYSE:GSK) has received a major boost for its experimental drug GSK5764227 (GSK'227), which targets a rare and aggressive bone cancer called osteosarcoma. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the treatment, which is being tested for patients whose cancer has returned after at least two prior treatments.
GSK's Nucala approved in China for treating nasal polyps
GSK PLC's (LSE:GSK, NYSE:GSK) Nucala (mepolizumab) has been approved in China to treat adults with chronic rhinosinusitis with nasal polyps (CRSwNP) when other therapies, like steroids or surgery, have not worked. This makes Nucala the first anti-interleukin-5 treatment available for this condition in China, where an estimated 30 million people live with CRSwNP.
GSK's FIRST trial achieves progression-free survival milestone in advanced ovarian cancer
GSK PLC (LSE:GSK, NYSE:GSK) has announced that its phase III FIRST-ENGOT-OV44 trial met its primary goal, or 'endpoint'. The study showed that the addition of Jemperli (dostarlimab) to platinum-based chemotherapy and Zejula (niraparib) maintenance, with or without bevacizumab, significantly improved progression-free survival (PFS) in first-line advanced ovarian cancer.
GSK's cancer drugs meet progression-free survival goal in late-stage trial
GSK said on Friday the addition of its cancer drug Jemperli to both standard of care chemotherapy and Zejula maintenance improved survival in patients with advanced ovarian cancer without the disease getting worse in a late-stage trial.
GSK Gets CHMP Nod for Expanded Use of HIV Combo & Jemperli
The CHMP recommends marketing approval to GSK's Vocabria plus JNJ's Rekambys for treating HIV-1 infection in adolescents aged 12 years and older.
GSK passes three significant milestones with new cancer drug given a double boost
GSK PLC (LSE:GSK, NYSE:GSK) has announced significant progress in its oncology pipeline, achieving three milestones. The European Medicines Agency (EMA) has issued a positive opinion recommending the expanded approval of Jemperli (dostarlimab) with chemotherapy for first-line treatment of advanced or recurrent endometrial cancer.
GSK Stock Declines 20% in 3 Months: Should You Buy, Sell or Hold?
Though GSK is definitely not the best large-cap drugmaker to have in one's portfolio, we believe there is potential for its sales and profits to improve.
GSK says blood cancer drug shows dramatic survival gains in key trial
GSK PLC (LSE:GSK, NYSE:GSK) shares in New York rose Monday afternoon after it announced that its blood cancer drug Blenrep (belantamab mafodotin) significantly extended survival in a pivotal trial. The drug, combined with two other therapies, reduced the risk of death by 42% compared to a rival treatment from Johnson & Johnson (NYSE:JNJ), according to results presented at the American Society of Hematology's annual meeting.
