FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Latest

May 08, 2020, 20:22 ET Lilly Receives U.S. FDA Approval for Retevmo? (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo? (selpercatinib, 40 mg & 80 mg...


May 08, 2020, 17:37 ET FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer,...


May 08, 2020, 09:00 ET FDA Permits Use of Aidoc's AI Algorithms to Detect and Prioritize Incidental CT Findings Associated With COVID-19

Aidoc - the leading provider of AI solutions for radiologists - announced today that the FDA has allowed the use of their cleared AI algorithms...


May 08, 2020, 08:38 ET Total Primary Care Offers the First COVID-19 Antibody Test in Texas Approved by FDA for EUA Use

Total Primary Care has become the first medical provider in Texas to secure and offer a COVID-19 antibody test approved by the US Food and Drug...


May 08, 2020, 08:30 ET FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast...


May 07, 2020, 12:56 ET Viracor Eurofins Launches Highly Accurate Antibody Tests for Coronavirus (COVID-19) SARS-CoV-2

Viracor Eurofins, Inc. (Viracor) a leading infectious disease testing laboratory for more than 35 years, announced the launch of its antibody assays...


May 07, 2020, 09:00 ET Grifols Procleix Panther System with Automation Ready Technology (ART) receives FDA Approval

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative...


May 07, 2020, 07:30 ET OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that the United States Food and Drug...


May 06, 2020, 19:40 ET Novartis announces FDA approval of MET inhibitor Tabrecta? for metastatic non-small cell lung cancer with METex14

Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta? (capmatinib, formerly INC280), an oral MET inhibitor for...


May 06, 2020, 16:01 ET Neurocrine Biosciences Reports First Quarter 2020 Financial Results

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2020 and provided revised...


May 06, 2020, 14:51 ET FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer

Today, the U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer...


May 06, 2020, 14:38 ET Novartis announces FDA approval of MET inhibitor Tabrecta? for metastatic non-small cell lung cancer with METex14

Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta? (capmatinib, formerly INC280), an oral MET inhibitor for...


May 06, 2020, 08:30 ET DarioHealth Self-test Blood Glucose Meters Can Now Be Utilized Within Hospitals During the COVID-19 Pandemic Per Recently Issued Emergency FDA Guidelines

DarioHealth Corp. (Nasdaq: DRIO), a global digital therapeutics (DTx) innovator, announced today that in an effort to reduce contact between...


May 06, 2020, 07:11 ET FDA Clears New Mechanical Thrombectomy Platform

Control Medical Technology announced the FDA cleared the Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral...


May 06, 2020, 02:00 ET Antabio Receives QIDP Designation From the U.S. FDA for the Development of MEM-ANT3310, a Novel Broad-Spectrum Combination Therapy Targeting WHO's Priority Pathogens

Antabio SAS, the biopharmaceutical company focused on developing a broad pipeline of antibacterial treatments against life threatening WHO critical...


May 05, 2020, 20:11 ET FDA approves new treatment for a type of heart failure

Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection...


May 05, 2020, 11:00 ET FDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients

VitalConnect?, Inc., a leader in wearable biosensor technology, announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food...


May 05, 2020, 08:00 ET FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial

Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S....


May 05, 2020, 08:00 ET Galderma Receives FDA Approval For Restylane? Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed And Indicated To Add Fullness To The Lips And Help Smooth The Wrinkles Above The Mouth

Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane? Kysse for lip augmentation and the correction of upper...


May 04, 2020, 13:01 ET Diverse Biotech announces orphan-drug designation for treatment of newly diagnosed glioblastoma

Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has granted an orphan-drug designation request...


May 04, 2020, 10:12 ET U.S. Food and Drug Administration Approves DARZALEX FASPRO? (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO?...


May 04, 2020, 10:06 ET New Corona Antibody Test Made in Germany "99.8% Accurate"

Roche launched the new serological (antibody-based) test at the company's Penzberg laboratory on Monday, May 4 at a press conference attended by...


May 04, 2020, 06:05 ET FDA Approves FENSOLVI? (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for FENSOLVI?...


May 01, 2020, 15:16 ET Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO? Utilizing Halozyme's ENHANZE? Technology For The Treatment Of Patients With Multiple Myeloma

Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S....


May 01, 2020, 08:00 ET FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for Humeral Cup Stability & Humeral Cup 135/145° Stability

FX received 510k clearances for their Humeral Cup Stability & Humeral Cup 135/145° Stability for reverse shoulder arthroplasty. The new additional...