FDA News

Medtronic Announces FDA Approves First-Of-Its-Kind Percept PC Neurostimulator with BrainSense Technology

DUBLIN, June 25, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announces it received Food and Drug Administration (FDA) approval for the Percept™ PC Deep Brain Stimulation (DBS) system. BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically …

Read More »

FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable …

Read More »

NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 for Treatment of Respiratory Distress in COVID-19

RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute …

Read More »

FDA Lifts Partial Clinical Hold on Innate Pharma’s Phase 2 Trial of Lacutamab in Advanced T-Cell Lymphomas

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in …

Read More »

FDA Announces First of its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has …

Read More »

AbbVie Submits sNDA to the FDA for Imbruvica in Combination with Rituximab in Waldenström’s Macroglobulinemia

NORTH CHICAGO, Ill., June 23, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare and incurable type of …

Read More »

FDA Approves Karyopharm’s Xpovio for Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO® (selinexor), the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), …

Read More »

FDA Grants Fast Track Designation to Polynoma’s Melanoma Cancer Vaccine Seviprotimut-L

SAN DIEGO, June 23, 2020 /PRNewswire/ — Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine …

Read More »

Roche Receives FDA Approval for cobas EZH2 Mutation Test as a Companion Diagnostic for Patients with Follicular Lymphoma

INDIANAPOLIS, June 19, 2020 /PRNewswire/ –Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™(tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma …

Read More »

FDA Grants Accelerated Approval to Epizyme’s Tazverik for Treatment of Relapsed/Refractory Follicular Lymphoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (Nasdaq:EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications: Adult patients with relapsed or …

Read More »