Breakthrough Therapy Designation Archives - Page 3 of 3

Genentech’s Esbriet Granted Breakthrough Therapy Designation for uILD

Breakthrough Therapy Designation, Clinical Trials, FDA, FDA/Regulatory, R&D, Therapeutics, unclassifiable Interstitial Lung Disease (uILD)

The U.S. Food and Drug Administration granted Breakthrough Therapy designation to Genentech’s Esbriet as a potential treatment for adults with unclassifiable interstitial lung disease (uILD) as the Roche subsidiary looks to expand the drug’s indications.

March 4, 2020/by BioSpace

U.S. FDA Approves Imbruvica For Rare Blood Cancer

Approvals, Blood Cancers, Breakthrough Therapy Designation, Bruton's Tyrosine Kinase (BTK) Inhibitors, FDA/Regulatory, First-In-Class, Hematological Cancers, New Indications, Non-Hodgkin Lymphoma, Waldenstrom’s macroglobulinemia

The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.

August 27, 2018/by PR Newswire

Tagrisso Granted Breakthrough Therapy Designation by US FDA for the 1st-Line Treatment of Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

Breakthrough Therapy Designation, Epidermal Growth Factor Receptor (EGFR), FDA, Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration granted Breakthrough Therapy Designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.

October 9, 2017/by Business Wire

2016 Annual Report: Top 10 Pipelines

"Bad" LDL Cholesterol, Alzheimer's Diseases, Approvals, Big Pharma, Biologics License Application (BLA), Biosimilars, Biotech, Biotech/Biopharma, Biotechnology, Bispecific CD19-directed CD3 T cell engager (BiTE) antibodies, Blockbusters, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Cells, Chimeric Antigen Receptor T Cell Therapy (CART), Cholesterol, Chronic Lymphocytic Leukemia, Clinical Trials, Collaboration, Collaborations, Collaborations, Cystic Fibrosis, Deals, Diabetes, DNA, EGFR Inhibitors, Europe, European Commission, FDA, FDA/Regulatory, February 2016, Glucagon-Like Peptide-1 (GLP-1) Analogs, Immune Response, Immune System, Immune Systems, Immunotherapies, Influenza, Inhalers, Issue Archives, Mantle Cell Lymphoma (MCL), Monoclonal Antibodies, Multiple Myeloma, NDA, Neuroscience, New Drug Application (NDA), New Molecular Entities, Non-Small Cell Lung Cancer, Oncology, Pain, Parkinson's, Parkinson's Disease, Plaque Psoriasis, Potential Blockbusters, Psoriasis, R&D, Sales, SGLT2 Inhibitors, Special Reports, Specialty Therapy, Technology, TGF-Beta Inhibitors, The New England Journal of Medicine (NEJM), Therapeutics, Top 10 Pipelines, Transforming Growth Factor-beta (TGFb), Type 1 Diabetes, Type 2 Diabetes, Vaccines, Waldenstrom’s macroglobulinemia

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

February 10, 2016/by Andrew Humphreys

Pivotal Phase II Study Showed Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Lung Cancer

Biotech, Breakthrough Therapy Designation, Health, Immunotherapy, Non-Small Cell Lung Cancer (NSCLC), PD-1/PD-L1 inhibitors, R&D, Studies

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that in the large pivotal Phase II study, BIRCH, the investigational cancer […]

August 17, 2015/by Business Wire