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Golden Biotechnology Corp., a Taiwanese biopharmaceutical company, said the FDA approved its investigational new drug application for a Phase II clinical trial of Antroquinonol (Hocena) on COVID-19 patients in USA. The phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol...

EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. (PFE) announced the US FDA has approved the supplemental Biologics License Application for BAVENCIO (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has...

colorectalcancer june30 Pharma major Merck & Co. said the U.S. Food and Drug Administration (FDA) approved its cancer drug Keytruda (pembrolizumab) for intravenous injection as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

rocheholding oct17 30jun20 The FDA has approved Roche Group's (RHHBY.OB) Phesgo regimen that can be administered subcutaneously in combination with intravenous chemotherapy for the treatment of HER2-positive breast cancer that has spread to other parts of the body and for the treatment of HER2-positive breast cancer at an early stage.

Biopharmaceutical company Incyte Corp. (INCY) announced Monday that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta is...

Boston Scientific Corp. (BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-DxInsertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic...

Alexion Pharmaceuticals Inc. (ALXN) said that the European Commission has approved Ultomiris for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome or aHUS who are complement inhibitor treatment-naïve or have received SOLIRIS for at least...

Citius Pharmaceuticals, Inc. (CTXR) said it has received a written response from the FDA with respect to the company's pre-investigational new drug application for induced mesenchymal stem cells to treat and reduce the severity of acute respiratory distress syndrome in patients with COVID-19. The FDA...

Allergan, an AbbVie Company (ABBV), and Molecular Partners announced the FDA has issued a Complete Response Letter to the Biologics License Application for Abicipar pegol, an investigational DARPin therapy for patients with neovascular age-related macular degeneration. The Response Letter indicates...

Zogenix Inc. (ZGNX) said that the U.S. Food and Drug Administration has approved Fintepla or fenfluramine oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. The company noted that Fintepla will be launched through a restricted distribution...

Allergan, an AbbVie (ABBV) company, announced the U.S. FDA has accepted the company's supplemental biologics license application to expand the BOTOX prescribing information for the treatment of signs and symptoms of detrusor overactivity associated with an underlying neurologic condition in pediatric...

Roche said that the U.S. Food and Drug Administration has approved the cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK or tazemetostat, developed by Epizyme Inc. The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year. The molecular test detects...

fdaapproval march25 19jun20 Biopharmaceutical company Ultragenyx Pharmaceutical Inc. said the U.S. Food and Drug Administration (FDA) approved its bone disease drug Crysvita (burosumab) in the form of injection for the treatment of tumor-induced osteomalacia (TIO) in patients aged two and older. Japanese specialty pharmaceutical company Kyowa Kirin Co., Ltd. is in collaboration with Ultragenyx for Crysvita globally.

Acasti Pharma Inc. (ACST) said the FDA has provided the company with a written response to its Type C Meeting request and briefing package. The FDA confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as contemplated in the original...

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that the National Medical Products Administration or NMPA in China has approved Dupixent or dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies...

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