Home / FDA News (page 30)

FDA News

Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) …

Read More »

FDA Expands Lilly’s Alimta Label to Include Combination Treatment for Metastatic Nonsquamous NSCLC

INDIANAPOLIS, June 5, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA®(pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 …

Read More »

FDA Grants Priority Review to Genentech’s Hemlibra for Patients with Hemophilia A without Factor VIII Inhibitors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® (emicizumab-kxwh) for adults and children with hemophilia A without factor …

Read More »

FDA Approves Mylan and Biocon’s Fulphila, the First Biosimilar to Neulasta

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018/PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever …

Read More »

FDA Grants Orphan Drug Designation to Alnylam’s Investigational RNAi Therapeutic for Treatment of Transthyretin-Mediated Amyloidosis

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to ALN-TTRsc02, an investigational RNAi therapeutic for the treatment of transthyretin-mediated amyloidosis. ALN-TTRsc02 has the potential to be a once-quarterly, low volume, subcutaneously …

Read More »

FDA Approves Olumiant for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis

INDIANAPOLIS, June 1, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation(NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or …

Read More »

FDA Lifts Partial Clinical Hold on Late-Stage Opdivo-Based Combination Study in Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision …

Read More »

Statement from FDA Commissioner on New Policies to Reduce of Brand Drug Makers to Use REMS to Block Generic Drug Entry

Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by Congress that seeks to balance access with innovation. That system enables market-based rewards for novel innovation as a way to create incentives for the time, risk and capital required to develop new medical advances. …

Read More »

FDA Puts Clinical Hold on CRISPR and Vertex’s IND Application for CTX001 for the Treatment of Sickle Cell Disease

BOSTON and ZUG, Switzerland and CAMBRIDGE, Mass., May 30, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions that will be …

Read More »

Pfizer’s Xeljanz Receives FDA Approval for Treatment of Moderately to Severely Active Ulcerative Colitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately …

Read More »