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Biopharmaceutical company Phathom Pharmaceuticals, Inc. (PHAT) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief...

kendamil may25 The U.S. Food and Drug Administration said it has taken steps to make available millions of cans of additional infant and specialty formula to U.S. consumers in the coming months. Under the agency's recent increased flexibilities, British nutrition products maker Kendal Nutricare will send about 2 million cans of infant formula under the Kendamil brand initially to U.S. beginning in June.

Dermavant Sciences, a subsidiary of biopharmaceutical company Roivant Sciences (ROIV), announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved VTAMA (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This...

United Therapeutics Corp. (UTHR), a public benefit corporation, announced Tuesday that the U.S. Food and Drug Administration has approved Tyvaso DPI (treprostinil) inhalation powder. The approval is for the treatment of pulmonary arterial hypertension or PAH and pulmonary hypertension associated with...

dupixent may23 The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals, Inc.'s Dupixent (dupilumab) to treat eosinophilic esophagitis or EoE, a chronic immune disorder. It is the first FDA approval to treat EoE in adults and pediatric patients 12 years and older weighing at least 40 kilograms.

ImmunoGen, Inc. (IMGN) announced Monday that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRa)-high platinum-resistant ovarian cancer who have been previously...

British drug major AstraZeneca PLC (AZN.L, AZN) announced Monday that its COVID-19 vaccine, Vaxzevria, has been granted approval in the European Union as a third dose booster in adults. The vaccine can now be used as a third dose booster in patients previously given a primary vaccine schedule of either...

Medical technologies firm Teleflex Inc. (TFX) announced Thursday that its UroLift System for treating benign prostatic hyperplasia or BPH has received regulatory clearance in China. The National Medical Products Administration or NMPA has approved the system, which is a minimally invasive treatment...

Medical technologies firm Teleflex Inc. (TFX) announced Wednesday that it received Health Canada approval for the MANTA Vascular Closure Device, the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure. This approval...

Alnylam Pharmaceuticals, Inc. (ALNY) announced Wednesday that Health Canada has issued a Notice of Compliance (NOC) authorizing OXLUMO (lumasiran) injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in paediatric and adult patients. OXLUMO...

Life sciences company Labcorp (LH) announced Wednesday the receipt of Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a combined at-home collection kit available that simultaneously detects COVID-19, influenza A/B and respiratory syncytial virus (RSV), a common...

The U.S. Food and Drug Administration approved Eli Lilly and Co.'s (LLY) Mounjaro or tirzepatide injection for the treatment of adults with type 2 diabetes. Mounjaro represents the first new class of diabetes medicines introduced in nearly a decade and is expected to be available in the U.S. in the coming...

Medtronic plc (MDT) has received FDA approval for the Onyx Frontier drug-eluting stent for the treatment of patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The Onyx Frontier DES is now approved in the U.S. and is pending CE Mark. The...

PolarityTE, Inc. (PTE) announced the FDA granted a Regenerative Medicine Advanced Therapy designation to SkinTE. RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products. Richard Hague, CEO, said: "The Agency...

Eli Lilly and Co. (LLY) and Incyte (INCY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane...

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