Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA
08 oct. 2024 07h00 HE
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Teva Pharmaceutical Industries Ltd
Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal womenTVB-009P, Teva’s proposed biosimilar to Prolia, showed...
ExCellThera Announces EMA’s Acceptance under Accelerated Assessment of Market Authorisation Application (MAA) for UM171 Cell Therapy for Patients with Hematological Malignancies who Lack a Readily Available Suitable Donor
25 juin 2024 07h00 HE
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ExCellThera
Market Authorisation Application (MAA) for ExCellThera's UM171 Cell Therapy accepted under accelerated assessment by the European Medicines Agency
InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)
30 août 2023 07h30 HE
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InflaRx N.V.
MAA for vilobelimab was submitted in JulyMAA has been validated by EMA and is now under reviewRegulatory submission based on pivotal data from PANAMO Phase III trialCompany announces attendance at...
European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Sarcoidosis
18 janv. 2023 08h00 HE
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aTyr Pharma, Inc.
SAN DIEGO, Jan. 18, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary...
ObsEva Provides Update on Yselty® (Linzagolix) Clinical Development Program
11 janv. 2021 01h00 HE
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ObsEva SA
- European Medicines Agency Validates Yselty MAA for Uterine Fibroids; US NDA Planned for 1H 2021 - Phase 3 EDELWEISS 3 (Conducted in Europe and US) Study of Yselty for Treatment of...
ObsEva SA Submits Marketing Authorization Application to the European Medicines Agency for YSELTY® (linzagolix) for the Treatment of Women with Uterine Fibroids
24 nov. 2020 01h00 HE
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ObsEva SA
If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management of uterine fibroids: 100 mg once daily for women with a contraindication to or who...
The European Medicines Agency Accepts the Regulatory Submission for Lumoxiti in Relapsed or Refractory Hairy Cell Leukemia
02 janv. 2020 01h00 HE
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INNATE PHARMA
MARSEILLE, France, Jan. 02, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the European Medicines...
Bellicum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
30 août 2019 16h08 HE
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Bellicum Pharmaceuticals, Inc.
HOUSTON, Aug. 30, 2019 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood...
Bellicum Pharmaceuticals to Participate in Three Healthcare Investor Conferences during September
28 août 2019 16h05 HE
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Bellicum Pharmaceuticals, Inc.
HOUSTON, Aug. 28, 2019 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood...
Bellicum Pharmaceuticals Announces Aggregate Gross Proceeds of $69.6 Million from $139.6 Million Public Offering and Private Placement
21 août 2019 16h05 HE
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Bellicum Pharmaceuticals, Inc.
HOUSTON, Aug. 21, 2019 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood...