October 18th, 2023

Shares of Sage Therapeutics, Inc. (Nasdaq: SAGE), a leading biopharmaceutical company specializing in neurological and neuropsychiatric disorders, surged over 5% in pre-market trading after the company said that the U.S. Food and Drug Administration . Read more

October 02nd, 2023

Shares of Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) surged by more than 20% in pre-market trading following the company's decision to discontinue its Phase 2b clinical trial of ibezapolstat, its lead antibiotic candidate, designed for the treatment . Read more

September 26th, 2023

Shares of Profound Medical Corp. (Nasdaq: PROF) surged by more than 10% in after-hours trading after it announced FDA clearance for its Thermal Boost module in conjunction with TULSA-PRO, which allows surgeons to treat various prostate conditions, in. Read more

September 20th, 2023

Shares of ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) plunged over 40% following the announcement that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for neffy (epinephrine na. Read more

September 15th, 2023

Shares of Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) surged over 10% after the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) for lifileucel due to resource constraints. The new target action date is . Read more

September 13th, 2023

Semtech Corporation (Nasdaq: SMTC), a technology company specializing in semiconductor solutions, reported earnings of $0.11 per share for the second quarter of fiscal 2024, surpassing the consensus EPS estimate of $0.02. Quarterly sales for Semtech . Read more

September 13th, 2023

Shares of Spirit Airlines, Inc. (NYSE: SAVE) experienced a dip in pre-market trading as it revised downwardly its third-quarter 2023 outlook. The company now anticipates revenues between $1.245 billion and $1.255 billion, a notable decrease from its . Read more

September 12th, 2023

Shares of Avalo Therapeutics, Inc. (Nasdaq: AVTX) surged by more than 40% following the company's announcement of a purchase agreement with AUG Therapeutics, LLC (AUG), wherein it will sell its rights, assets, and interests related to the 800 Series . Read more

September 01st, 2023

Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products Washington D.C. / CRWE PRESS RELEASE / September 1, 2023 -   The Federal Tra. Read more

August 31st, 2023

Shares of 23andMe Holding Co. (Nasdaq: ME) surged over 5% in after-hours trading as the company announced an FDA 510(k) clearance to expand its Genetic Health Risk Report related to BRCA1/BRCA2 variants. This clearance now permits 23andMe to provide . Read more

August 30th, 2023

Shares of Outlook Therapeutics, Inc. (Nasdaq: OTLK) plummeted over 50% in pre-market trading following the company's announcement of receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics L. Read more

August 15th, 2023

Shares of Delcath Systems, Inc. (Nasdaq: DCTH) surged over 50% following the announcement of FDA approval for HEPZATO KIT (melphalan/Hepatic Delivery System).  This liver-directed therapy is now authorized for adult patients battling metastat. Read more

August 09th, 2023

Shares of Galera Therapeutics, Inc.? (Nasdaq: GRTX) plunged over 70% in after-hours trading as the company received a Complete Response Letter (CRL) from the FDA, addressing its New Drug Application (NDA) for avasopasem manganese, a potential treatme. Read more

August 05th, 2023

Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) have received U.S. Food and Drug Administration (FDA) approval for ZURZUVAE (zuranolone) 50 mg, offering a groundbreaking 14-day oral treatment for postpartum depression (PPD) in a. Read more

August 04th, 2023

Mesoblast Limited (Nasdaq: MESO) has announced the receipt of a comprehensive response from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) resubmission for remestemcel-L. The FDA's response stipulates the . Read more