Tag: FDA

Older and high-risk populations can now receive Pfizer vaccine booster dose, FDA says

Frank

USA – People above 65 years and adults at high risk of severe COVID-19 infection are now eligible to receive Pfizer/BioNTech’s booster dose vaccine, following emergency use authorization by the Food and Drug Administration (FDA). The decision paves the way for millions of people who received their second dose of the vaccine at least six months ago to receive booster shots as soon as they can. This emergency use authorization was based on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related…

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Big win for Paige Prostate as FDA grants approval for use in digital pathology

Frank

USA- The FDA has approved the sale of software, Paige Prostate, designed to assist pathologists in the detection of prostate cancer. Paige prostate is the first artificial intelligence (AI)-based pathology product to be approved by the FDA, and it is used in conjunction with the company’s previously approved FullFocus digital pathology viewer designed to identify areas on a prostate biopsy that are most likely to be cancerous. The FDA granted approval based on the results of a study in which 6 pathologists examined 527 digitally scanned prostate biopsy slides. There…

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Biogen’s wet AMD drug receives US FDA nod posing competition to Roche’s Lucentis

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USA – Biogen Inc together with Samsung Bioepis Company Limited have announced that the USFDA has granted their neovascular age-related macular degeneration (wet AMD) drug, Ranibizumab, approval for use against macular edema. This drug will be in competition with Lucentis, Roche’s blockbuster drug which was approved in 2006 and has accumulated sales of over US$1.61 billion in U.S. this past year. FDA’s approval is another win for Biogen, which in the recent months has been hitting headlines due to its controversial yet trendsetting Alzheimer’s drug Aduhelm. Ranibizumab is an anti-vascular…

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Zydus Cadila gets US-FDA nod for antidepressant drug

Frank

INDIA – Zydus Cadila received final approval from the US Food Drug Administration to sell new generation anti-depressant Vortioxetine in the strengths of 5 mg, 10 mg, 20 mg in US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Vortioxetine works by increasing serotonin in the brain by preventing the elimination and reuptake of seratonin in the brain, and is classified as a selective serotonin reuptake inhibitor and serotonin receptor modulator. Zydus has been on a…

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U.S. FDA approves Takeda’s lung cancer therapy

Frank

JAPAN – Japanese pharma company Takeda Pharmaceutical has been granted approval for its drug, Exkivity, to treat a type of lung cancer by the U.S. Food and Drug Administration. Takeda said the approval was based on an early-to-mid-stage trial testing 114 patients with non-small cell lung cancer, with results showing clinically meaningful responses with a median duration of about 18 months. Exkivity was approved for patients with a specific gene mutation called EGFR Exon20 insertions in non-small cell lung cancer, whose disease has progressed on or after chemotherapy. The company…

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Granules India and Jubilant Cadista recall pharmaceutical products from US market

Frank

INDIA – Generic drug makers Granules India and Jubilant Cadista are recalling different products in the US, the world’s largest market for medicines, for different reasons. As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling a batch of Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever. According to USFDA, the company’s US-based unit is recalling the affected lot due to “Current Good Manufacturing Practice…

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FDA says will follow the science to approve COVID vaccine for kids under 12

Frank

USA – The US FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation. The FDA leaders said they are “eager to see COVID-19 vaccines available for young…

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FDA approves Cara’s drug for severe itching in kidney disease patients

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USA – The Food and Drug Administration has approved Cara Therapeutics’s drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making it the first therapy for the ailment in the United States. The company expects to commercially launch the injection, Korsuva, in the first quarter of 2022, Chief Executive Officer Derek Chalmers said in an interview. The drug is designed to be administered three times a week after each dialysis. It reduces the activity of the sensory nerve that relays itching from the skin to the…

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Pfizer becomes first ever COVID-19 vaccine to gain FDA’s full approval

Frank

USA – The Food and Drug Administration (FDA) has granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older, and will now be marketed as Comirnaty. The approval is expected to set off more vaccine mandates by employers and organizations across the USA. It comes amid lingering vaccine hesitancy among many Americans. Even so, out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine. In a statement, the FDA said its review for…

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Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity

Frank

INDIA – Drug firm Zydus Cadila has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market. The company said it has received approval from the US Food and Drug Administration (USFDA) for the drug in 11 mg and 22 mg strengths. Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength, the company said in a statement. Arthritis, or joint disease, is inflammation…

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