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Athenex, Inc. (ATNX) said its Marketing Authorization Application for oral Paclitaxel for the treatment of advanced breast cancer has been validated by the United Kingdom's Medicines and Healthcare products Regulatory Agency for review. A single pivotal phase III study of oral Paclitaxel was the basis...

Viracta Therapeutics, Inc. (VIRX) announced the FDA has granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified. Ivor Royston, CEO...

Bristol Myers Squibb (BMY) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to...

takedafda nov25 The U.S. Food and Drug Administration has approved Takeda Pharmaceuticals Co. Ltd.'s Livtencity (maribavir) as the first drug to treat post-transplant cytomegalovirus or CMV in adults and pediatric patients. The approval is to treat patients 12 years of age and older and weighing at least 35 kilograms with post-transplant CMV infection/disease that does not respond...

Janssen, the pharmaceutical companies of Johnson & Johnson (JNJ), announced that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. "We are delighted by Health Canada's decision to approve the Johnson & Johnson COVID-19 vaccine...

vaccine dec28 19nov21 Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Friday that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered...

Biotechnology company Moderna, Inc. (MRNA) announced Friday that the U.S. Food and Drug Administration (FDA) has extended the emergency use authorization (EUA) of a booster dose of the Moderna COVID-19 vaccine at the 50 mcg dose level to all adults aged 18 and older. This booster can be used in all...

Clinical-stage biopharmaceutical company Gracell Biotechnologies Inc. (GRCL) announced the FDA has granted Orphan Drug Designation for GC012F, the company's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma. GC012F is currently being evaluated in investigator-initiated...

virtualrealitysystem nov17 The U.S. Food and Drug Administration has authorized marketing of virtual reality or VR system, EaseVRx, to reduce chronic pain. EaseVRx, manufactured by AppliedVR, is a prescription-use immersive VR system that uses principles of cognitive behavioral therapy or CBT and other behavioral methods for the purpose of reduction of pain and pain interference.

AbbVie (ABBV) announced that the European Union's European Commission has approved SKYRIZI (risankizumab) for the treatment of adults with active psoriatic arthritis. Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients...

Shares of INOVIO (INO) surged 6% in pre-market trade on Tuesday as the FDA has lifted the partial clinical hold on INNOVATE phase 3 segment. This provides authorization to proceed for INNOVATE phase 3 segment for its COVID-19 vaccine candidate, INO-4800, in the U.S. The global phase 3 segment of...

Talis Biomedical Corporation (TLIS) said the FDA has granted Emergency Use Authorization for its Talis One COVID-19 Test System. It enables sample-to-answer molecular testing in less than 30 minutes. COVID-19 is the first infectious disease that the Talis One system is designed to detect. Kim Popovits,...

Biotechnology company Novavax, Inc. (NVAX) and Serum Institute of India Pvt. Ltd. or SII, the world's largest vaccine manufacturer by volume, announced Monday that NVX-CoV2373 COVID-19 Vaccine has received emergency use authorization or EUA in Indonesia. In pre-market activity on Nasdaq, Novavax shares...

ANI Pharmaceuticals, Inc. (ANIP, BPAX) announced FDA has approved its supplemental New Drug Application (sNDA) for Purified Cortrophin Gel for the treatment of certain chronic autoimmune disorders including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome. The company anticipates a full-scale...

Swiss drug major Novartis (NVS) announced Monday that the US Food and Drug Administration approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia or CML in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive...

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