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October 08, 2024 07:00 ET | Source: Teva Pharmaceutical Industries Ltd

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

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...
June 25, 2024 07:00 ET | Source: ExCellThera

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

Market Authorisation Application (MAA) for ExCellThera's UM171 Cell Therapy accepted under accelerated assessment by the European Medicines Agency
August 30, 2023 07:30 ET | Source: InflaRx N.V.

InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)

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...
January 18, 2023 08:00 ET | Source: aTyr Pharma, Inc.

European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Sarcoidosis

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...
January 11, 2021 01:00 ET | Source: ObsEva SA

ObsEva Provides Update on Yselty® (Linzagolix) Clinical Development Program

- 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...
November 24, 2020 01:00 ET | Source: ObsEva SA

ObsEva SA Submits Marketing Authorization Application to the European Medicines Agency for YSELTY® (linzagolix) for the Treatment of Women with Uterine Fibroids

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...
January 02, 2020 01:00 ET | Source: INNATE PHARMA

The European Medicines Agency Accepts the Regulatory Submission for Lumoxiti in Relapsed or Refractory Hairy Cell Leukemia

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...
August 30, 2019 16:08 ET | Source: Bellicum Pharmaceuticals, Inc.

Bellicum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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...
August 28, 2019 16:05 ET | Source: Bellicum Pharmaceuticals, Inc.

Bellicum Pharmaceuticals to Participate in Three Healthcare Investor Conferences during September

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...
August 21, 2019 16:05 ET | Source: Bellicum Pharmaceuticals, Inc.

Bellicum Pharmaceuticals Announces Aggregate Gross Proceeds of $69.6 Million from $139.6 Million Public Offering and Private Placement

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...