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RSS FeedPosted by Michael Wonder on 22 Dec 2020
FDA approves treatment for Ebola virus
21 December 2020 - The U.S. FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) ...
Posted by Michael Wonder on 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 21 Dec 2020
The FDA grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma
15 December 2020 - IO Biotech today announced that the U.S. FDA has granted breakthrough therapy designation for a combination ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 21 Dec 2020
Vertex announces FDA approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations
21 December 2020 - More than 600 people with certain rare cystic fibrosis mutations are now eligible for Trikafta, Symdeko or ...
Posted by Michael Wonder on 21 Dec 2020
Oyster Point Pharma submits new drug application to the U.S. FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
18 December 2020 - The new drug application submission is based on efficacy and safety results from a comprehensive clinical trial ...
Posted by Michael Wonder on 21 Dec 2020
U.S. FDA approves supplemental new drug application for Takeda’s Iclusig (ponatinib) for adult patients with resistant or intolerant chronic phase CML
19 December 2020 - Approval based on data from the Phase 2 OPTIC trial, which evaluated response-based Iclusig dosing regimens in ...
Posted by Michael Wonder on 20 Dec 2020
Hikma launches generic Advair Diskus following FDA approval
17 December 2020 - Hikma Pharmaceuticals announces it has received FDA approval for and launched its generic version of GlaxoSmithKline’s ...
Posted by Michael Wonder on 19 Dec 2020
Karyopharm announces FDA approval of Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy
18 December 2020 - Oral Xpovio now available as a treatment option for patients with multiple myeloma as early as first ...
Posted by Michael Wonder on 19 Dec 2020
FDA takes additional action in fight against COVID-19 by issuing emergency use authorisation for second COVID-19 vaccine
18 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...
Posted by Michael Wonder on 18 Dec 2020
Novartis receives complete response letter from U.S. FDA for inclisiran
18 December 2020 - The U.S. FDA has not raised any concerns related to the efficacy or safety of inclisiran. The ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first adjuvant therapy for most common type of lung cancer
18 December 2020 - Today, the U.S. FDA approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first oral hormone therapy for treating advanced prostate cancer
18 December 2020 - Today, the U.S. FDA approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. ...
Posted by Michael Wonder on 18 Dec 2020
Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy
18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...
Posted by Michael Wonder on 18 Dec 2020
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of advanced systemic mastocytosis
17 December 2020 - Blueprint Medicines today announced the submission of a supplemental new drug application to the U.S. Food FDA ...