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06/09/21 11:04 AM
Nasdaq : VRTX
CORRECTING and REPLACING Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
First paragraph, third sentence of release should read: An additional dosage strength of TRIKAFTA tablets is now available (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg and ivacaftor 75 mg)...(instead of An additional dosage strength of TRIKAFTA tablets is now available (elexacaftor 50
RHEA-AI
very positive
06/09/21 8:00 AM
Nasdaq : VRTX
Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del
RHEA-AI
positive
05/28/21 2:30 PM
Nasdaq : BBIO
BridgeBio Pharma’s Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of TRUSELTIQ™ (infigratinib) for Patients with Cholangiocarcinoma
Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement BridgeBio, through its affiliate QED (“BridgeBio”), and
RHEA-AI
very positive
05/28/21 1:45 PM
NYSE : QGEN
QIAGEN Launches First FDA-approved Tissue Companion Diagnostic to Identify the KRAS G12C Mutation in NSCLC Tumours and Expand Precision Medicine Options in Lung Cancer
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of an expanded scope of companion diagnostic (CDx) claims for the therascreen ® KRAS RGQ PCR Kit ( therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the
RHEA-AI
very positive
05/28/21 1:15 PM
Nasdaq : GH
Guardant360® CDx Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer
Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 ® CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced
RHEA-AI
very positive
05/27/21 8:05 AM
Nasdaq : OTLK, OTLKW
Virtual Clinical Day Recap: Outlook Therapeutics Joined by Drs. Mark Humayun and Firas Rahhal to Discuss Need for FDA-Approved Ophthalmic Bevacizumab and Status of ONS-5010
Drs. Mark Humayun and Firas Rahhal, leading retinal specialists and Advisors to Outlook Therapeutics, stress clinical value of ONS-5010, if approved, over existing treatment options Registration clinical program and pre-commercialization planning for ONS-5010 remains ongoing with key catalysts
RHEA-AI
neutral
05/27/21 7:00 AM
Nasdaq : LNTH
Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer
Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U.S. Food and
RHEA-AI
neutral
05/26/21 4:15 PM
NYSE : MYOV
Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids
In the Phase 3 LIBERTY 1 and LIBERTY 2 studies, MYFEMBREE demonstrated 72.1% and 71.2% response rates in menstrual blood loss (MBL) at Week 24, with MBL reductions of 82.0% and 84.3% from baseline Myovant and Pfizer will jointly commercialize MYFEMBREE, with product availability expected in June
RHEA-AI
very positive
05/21/21 3:14 PM
Nasdaq : GH
Guardant360® CDx Receives FDA Approval as Companion Diagnostic for Janssen’s RYBREVANT™ (amivantamab-vmjw) for Use in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 ® CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT™ (amivantamab-vmjw).The Guardant360 CDx test will be
RHEA-AI
very positive
05/05/21 4:05 PM
NYSE : MRK
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line
RHEA-AI
neutral
04/28/21 4:00 PM
OTC : RHHBY
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or
RHEA-AI
very positive