Tag: approves

Spain’s medicines agency approved Tuesday a first round of clinical trials on humans for a COVID-19 vaccine developed by Spanish firm Hipra. “This is the first trial on humans of a vaccine made in Spain,” the agency said in a statement. Dozens of volunteers will be recruited from Spanish hospitals “as soon as possible” for

India gave emergency approval to Johnson and Johnson’s single-shot coronavirus vaccine Saturday to ramp up its flailing immunisation campaign as fears grow of a new wave of infections. Health minister Mansukh Mandaviya said the approval will boost the fight against the pandemic in India, where at least 200,000 people died in a brutal two-month wave

Britain on Friday approved the use of the single shot Johnson & Johnson coronavirus vaccine, the Medicines and Healthcare products Regulatory Agency (MHRA) announced. “This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved

The European Union’s medicines watchdog on Wednesday approved a second coronavirus vaccine, in a relief to struggling European countries as the world reached a grim new record of 15,700 deaths in 24 hours. The Moderna vaccine is now set to join Pfizer-BioNTech’s jab for use in the 27-nation EU, where governments are grappling with soaring

U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago. The ruling marks the second time the Food and Drug Administration has granted preliminary approval for the disease based on early results and is likely to

(HealthDay)—The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma (PTCL). The FDA stated in a press release that this approval is the first for treatment of newly diagnosed PTCL. Adcetris, a monoclonal

The standard of care for kidney cancer patients continues to improve. The U.S. Food and Drug Administration granted approval to the combination of two immunotherapy drugs, ipilimumab and nivolumab, for the treatment of metastatic kidney cancer. The results of the large, international clinical trial leading to the approval were just published the prestigious New England

(HealthDay)—The lives of contact lens wearers just got a whole lot easier. On Tuesday, the U.S. Food and Drug Administration approved the first contact lenses that can act like sunglasses. A special additive automatically darkens the lenses when exposed to bright light, while they become clear again in normal or dark lighting conditions. “This contact