FDA

Shares of uniQure N.V. (NASDAQ:QURE) pumped around 78% on Wednesday after the FDA cleared the path for a uniQure AMT-130 FDA approval filing under the accelerated pathway — a dramatic reversal from the agency’s prior stance that had sent the stock to a 52-week low of $8.73. What Happened: The...

The U.S. FDA on Thursday approved an expanded indication for Merck & Co Inc.’s (NYSE:MRK) Capvaxive, extending its use to children and adolescents ages 2–17 with chronic conditions who have completed a primary pneumococcal vaccine series. The decision makes Capvaxive the only pneumococcal...

GSK plc (NYSE:GSK) and Spero Therapeutics, Inc. (NASDAQ:SPRO) announced on Wednesday that the U.S. Food and Drug Administration has approved Utebzi (tebipenem pivoxil hydrobromide), an oral antibiotic for adults with complicated urinary tract infections (cUTIs). First Oral Carbapenem Approved For...

uniQure N.V. (NASDAQ:QURE) stock is up during Wednesday’s premarket session as the company announced plans for a Biologics License Application (BLA) submission for AMT-130, a gene therapy treatment for Huntington’s disease. FDA Opens Accelerated Approval Path This news comes following a...

Outlook Therapeutics Inc. (NASDAQ:OTLK) shares are rising in Wednesday premarket trading after the company announced the FDA accepted its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA. The FDA acknowledged receipt of the application on Tuesday. If approved, ONS-5010/LYTENAVA...

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thursday, June 18, to discuss approval of Moderna Inc.’s (NASDAQ:MRNA) experimental mRNA-based flu vaccine. FDA Advisory Committee To Review Moderna Flu...

Cuprina Holdings (Cayman) Limited (NASDAQ:CUPR) shares are trending on Monday. CUPR shares fell 22.47% to $6.52 in after-hours trading on Monday. The stock of the Singapore-based biomedical company developing wound care and biotechnology products surged 111.84% intraday to $8.41, according to...

The U.S. Food and Drug Administration has granted accelerated approval to Sanofi SA’s (NASDAQ:SNY) Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 who have been recently diagnosed with stage 3 type 1 diabetes (T1D). The decision expands...

The U.S. Food and Drug Administration (FDA) on Friday cleared Dexcom Inc.‘s (NASDAQ:DXCM) Stelo Glucose Biosensor System for over-the-counter use in children ages 2 and older who do not use insulin, expanding access to continuous glucose monitoring for younger patients. The FDA previously...

AstraZeneca Plc (NYSE:AZN) received two significant regulatory updates from the U.S. Food and Drug Administration, with its cancer therapy Truqap gaining approval for a subset of prostate cancer patients and its kidney disease treatment Ultomiris receiving Priority Review for a new indication....

Lexeo Therapeutics Inc. (NASDAQ:LXEO) stock rose Monday as the company announced a regulatory update regarding its pivotal SUNRISE-FA 2 trial for gene therapy candidate LX2006. LXEO Stock Jumps The gene therapy company finalized the protocol for its SUNRISE-FA 2 pivotal trial, which aims to...

Amgen Inc. (NASDAQ:AMGN) has formally requested a hearing to challenge the U.S. Food and Drug Administration‘s proposal to withdraw approval for Tavneos (avacopan). The company argues that the drug's benefits continue to outweigh its risks for patients with a rare autoimmune disease. The...

Alterity Therapeutics Limited (NASDAQ:ATHE) stock is up during Tuesday’s session as the biotechnology company announced an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its pivotal Phase 3 program for ATH434 in treating Multiple System Atrophy (MSA). The...

A new artificial intelligence-powered cancer detection tool is under review by the Food and Drug Administration and could become the first device of its kind approved in the U.S., according to a Newsweek report. The company behind the technology said it hopes to launch the tool next year if it...