Gilead Sciences, Inc.

1747 articles with Gilead Sciences, Inc.

• Gilead Sciences Presents Data From HIV Research and Development Programs at HIV Glasgow 2020

  9/30/2020

  -- New Findings on Biktarvy ® to Include Long-term Switch Studies as well as Real-World Data and Patient Reported Outcomes from the BICSTaR Study -- -- Data Evaluating Drug Resistance in People Receiving Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor, as Part of a Long-acting HIV Treatment Regimen to be Presented -- FOSTER CITY, Calif.--( BUSINESS WIRE )-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming

• Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis

  9/25/2020

  Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile Through 52 Weeks in Clinical Trials

• European Commission Grants Marketing Authorization for Jyseleca® ▼ (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis

  9/25/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral,

• Gilead Sciences Prices $7.25 Billion of Senior Unsecured Notes - Sep 24, 2020

  9/24/2020

  Gilead Sciences, Inc. announced the pricing of senior unsecured notes in an aggregate principal amount of $7.25 billion, in an underwritten, registered public offering, consisting of seven tranches

• 

  Gilead Settles Kickback Claims with U.S. Government for $97 Million

  9/24/2020

  The company allegedly used a foundation as a conduit to pay the copays of Medicare patients who were taking Letairis, Gilead’s pulmonary arterial hypertension drug.

• Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome

  9/15/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS).

• 

  Gilead Moves Deeper into Oncology with $21 Billion Acquisition of Immunomedics

  9/14/2020

  The deal, announced Sunday, has been unanimously approved by the boards of directors of both companies.

• Gilead Sciences to Acquire Immunomedics

  9/13/2020

  Gilead Adds TrodelvyTM, First-in-Class Antibody-Drug Conjugate Approved to Treat Triple-Negative Breast Cancer, With Promise in Other Forms of Breast Cancer and Additional Solid Tumors

• Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for Novel Immunotherapy Program

  9/1/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program.

• 

  Gilead and Jounce Ink Potential $805 Million Immuno-Oncology Pact

  9/1/2020

  Gilead Sciences and Jounce Therapeutics entered a discovery and development deal to exclusively license Jounce’s JTX-1811 immuno-oncology program.

• Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19

  8/28/2020

  Gilead’s Investigational Antiviral Veklury ® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19 -- Expands Previous Authorization of Veklury to Treat Hospitalized Patients with COVID-19 Regardless of Oxygen Status -- FOSTER CITY, Calif.--( BUSINESS WIRE )-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) expanded

• Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020

  8/25/2020

  Full Results From Phase 2 ATLAS Study Support Potential for Combination Approaches for the Treatment of Patients With Advanced Fibrosis Due to NASH

• 

  FDA Rejects Gilead's Rheumatoid Arthritis Drug Over Safety Concerns

  8/19/2020

  The company indicates the agency requested data from the MANTA and MANTA-Ray trials before completing its review.

• Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis

  8/18/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).

• Gilead Sciences and Tango Therapeutics to Expand Strategic Oncology Collaboration

  8/17/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) and Tango Therapeutics today announced an expanded strategic collaboration focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for patients with cancer.

• China National Medical Products Administration Approves Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

  8/11/2020

  Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF).

• Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury® (Remdesivir) for the Treatment of COVID-19

  8/10/2020

  Veklury is Currently Available in the U.S. for the Treatment of Severe COVID-19 Under an Emergency Use Authorization

• 

  Kite, a Gilead Company, Looks to Expand Its Cell Therapy Maryland Operations

  8/10/2020

  Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer.
• 

  FDA Action Alert: Fennec, Gilead/Kite, Deciphera and Jazz/PharmaMar

  8/10/2020

  Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.

• Pfizer Announces Agreement with Gilead to Manufacture Remdesivir for Treatment of COVID-19

  8/7/2020

  Pfizer Inc. (NYSE: PFE) today announced a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility t