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Your search keyword '"Independent regulatory commissions -- Health aspects"' showing total 15 results
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15 results on '"Independent regulatory commissions -- Health aspects"'

1. Sentynl Therapeutics Receives MHRA Authorization of NULIBRY (fosdenopterin) for Treatment of MoCD Type A in Great Britain

Subjects
United States. Food and Drug Administration, Independent regulatory commissions -- Health aspects, Drug approval -- Health aspects, Business, News, opinion and commentary, Nulibry (Medication) -- Health aspects
Abstract

NULIBRY is the first and only treatment in Great Britain for patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants [...]

Published
2024

2. Karyopharm and Menarini Group Receive Full Marketing Authorization from the UK Medicines & Healthcare Products Regulatory Agency for NEXPOVIO (selinexor) in Combination with Bortezomib and Dexamethasone for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy

Subjects
Independent regulatory commissions -- Health aspects, Central nervous system depressants -- Health aspects, Bortezomib -- Health aspects, Dexamethasone -- Health aspects, Multiple myeloma -- Health aspects, Marketing -- Health aspects, Business, News, opinion and commentary, Xpovio (Medication) -- Health aspects
Abstract

-- Based on Results from Phase 3 BOSTON Study, Marketing Authorization Expands Multiple Myeloma Indication -- NEWTON, Mass. and FLORENCE, Italy, Feb. 21, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), [...]

Published
2023

3. Novavax Nuvaxovid(TM) COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the United Kingdom for Use in Adolescents Aged 12 Through 17

Subjects
Novavax Inc., Independent regulatory commissions -- Health aspects, Teenagers -- Health aspects, Youth -- Health aspects, Vaccines -- Health aspects, Marketing -- Health aspects, Severe acute respiratory syndrome -- Prevention, Coronaviruses -- Health aspects, Business, News, opinion and commentary, Nuvaxovid (Vaccine) -- Health aspects
Abstract

Nuvaxovid(TM) will be the first protein-based vaccine available for adolescents aged 12 through 17 in the United Kingdom GAITHERSBURG, Md., Aug. 26, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a [...]

Published
2022

4. AMIVAS Ireland Ltd. Receives Authorisation from the Medicines & Healthcare Products Regulatory Agency (MHRA) to Market Artesunate Amivas (artesunate) in U.K. for Initial Treatment of Severe Malaria

Subjects
United States. Centers for Disease Control and Prevention, Independent regulatory commissions -- Health aspects, Malaria -- Drug therapy, Business, News, opinion and commentary
Abstract

WATERFORD, Ireland, June 13, 2022 /PRNewswire/ -- https://c212.net/c/link/?t=0&l=en&o=3564590-1&h=371003473&u=https%3A%2F%2Famivas.eu%2F&a=AMIVAS+Ireland+Ltd., specialists in treatments for rare and neglected tropical diseases, including severe malaria, announced today the Medicines & Healthcare Products Regulatory Agency (MHRA) [...]

Published
2022

5. Moleculin Receives Approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for Protocol Amendment to Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19

Subjects
Independent regulatory commissions -- Health aspects, Clinical trials -- Health aspects, Business, News, opinion and commentary
Abstract

-- Dosing for first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers and establish maximum tolerated dose expected to commence imminently -- HOUSTON, May 10, [...]

Published
2022

6. UK Authorizes Regeneron Antibody Cocktail to Prevent and Treat Acute COVID-19 Infection

Subjects
United States. Food and Drug Administration, Regeneron Pharmaceuticals Inc., Roche Products Ltd., Independent regulatory commissions -- Health aspects, Viral antibodies -- Health aspects, Antibodies -- Health aspects, Monoclonal antibodies -- Health aspects, Pharmaceutical industry -- Health aspects, Business, News, opinion and commentary
Abstract

TARRYTOWN, N.Y., Aug. 20, 2021 /PRNewswire/ -- UK chief medical officers to confirm how antibody cocktail will be rolled-out on the National Health Service (NHS) in the coming weeks In [...]

Published
2021

7. Integral Molecular's Rapid SARS-CoV-2 Epitope Mapping Supports Regulatory Requirements for the Development of Therapeutic Antibodies Effective Against Viral Variants

Subjects
Biopharmaceutics -- Health aspects, Regulatory compliance -- Health aspects, Independent regulatory commissions -- Health aspects, Protein binding -- Health aspects, Antigenic determinants -- Health aspects, Viral antibodies -- Health aspects, Antibodies -- Health aspects, Business, News, opinion and commentary
Abstract

PHILADELPHIA, June 11, 2021 /PRNewswire/ -- At the forefront of the fight against COVID-19, Integral Molecular's rapid Epitope Mapping technology is being used to pinpoint precise binding sites of therapeutic [...]

Published
2021

8. Karyopharm Receives Conditional Marketing Authorization in the United Kingdom (UK) for NEXPOVIO (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma

Subjects
Independent regulatory commissions -- Health aspects, Central nervous system depressants -- Health aspects, Diseases -- Relapse, Dexamethasone -- Health aspects, Cancer -- Care and treatment, Carfilzomib -- Health aspects, Multiple myeloma -- Health aspects, Marketing -- Health aspects, Business, News, opinion and commentary, Xpovio (Medication) -- Health aspects
Abstract

-- NEXPOVIO is the First and Only Nuclear Export Inhibitor Authorized in the UK -- NEWTON, Mass., June 2, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical [...]

Published
2021

9. Karyopharm Announces XPOVIO (selinexor) Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma

Subjects
Independent regulatory commissions -- Health aspects, Lymphomas -- Development and progression, Dexamethasone -- Health aspects, Cancer -- Care and treatment, Multiple myeloma -- Development and progression, Pharmaceutical industry -- International economic relations, Business, News, opinion and commentary, Xpovio (Medication) -- Health aspects
Abstract

NEWTON, Mass., Feb. 4, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its partner Promedico Ltd., a member of the [...]

Published
2021

10. Codagenix and Serum Institute of India Announce Commencement of First-in-Human Trial of COVI-VAC, A Single Dose, Intranasal Live Attenuated Vaccine for COVID-19

Subjects
BCG vaccines -- Product development, Independent regulatory commissions -- Health aspects, BCG -- Product development, Clinical trials -- Health aspects, Vaccines -- Product development, Business, News, opinion and commentary
Abstract

- Randomized, double-blind, placebo-controlled, dose-escalation trial - 48 volunteers to be enrolled at three dose levels - Endpoints include safety, tolerability and immunogenicity NEW YORK and PUNE, India, Dec. 14, [...]

Published
2020

11. Aridis Announces Agreement with the FDA on Updated Phase 2 Clinical Trial Design for AR-501

Subjects
United States. Food and Drug Administration, Cystic fibrosis -- Health aspects, Independent regulatory commissions -- Health aspects, Infection -- Health aspects, Clinical trials -- Health aspects, Business, News, opinion and commentary
Abstract

SAN JOSE, Calif., Sept. 8, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, [...]

Published
2020

12. Cytocom, Inc. Announces Successful Completion of Type-B Pre-IND Meeting with FDA Regarding Proposed Phase 2 Clinical Trial of CYTO-201 in COVID-19 Patients

Subjects
Independent regulatory commissions -- Health aspects, Clinical trials -- Health aspects, Business, News, opinion and commentary
Abstract

WINTER PARK, Fla., June 29, 2020 /PRNewswire/ -- Cytocom, Inc. (Cytocom), a private clinical-stage biopharmaceutical company developing novel immune modulating therapies targeting cancer, autoimmune, inflammatory, and infectious diseases based on [...]

Published
2020

13. Elevate Health Sciences Receives one of Industry's Most Rigorous Certifications from the Therapeutic Goods Administration (TGA) in Australia

Subjects
NSE Inc., Safety regulations -- Health aspects, Independent regulatory commissions -- Health aspects, Dietary supplements -- Health aspects, Commercial finance companies -- Health aspects, Business, News, opinion and commentary
Abstract

PROVO, Utah, Oct. 2, 2019 /PRNewswire/ -- Elevate Health Sciences today announced it has been granted certification from Australia's Therapeutic Goods Administration (TGA). The TGA is considered one of the [...]

Published
2019

14. MYR Pharma Announces Grant of Promising Innovative Medicine (PIM) Designation by British MHRA for Bulevirtide (Myrcludex), the First-in-Class Entry Inhibitor for Treatment of Chronic Hepatitis D Infections

Subjects
Independent regulatory commissions -- Health aspects, Drugs -- Health aspects, Infection -- Drug therapy -- Health aspects, Business, News, opinion and commentary
Abstract

BURGWEDEL, Germany, March 5, 2019 /PRNewswire/ -- MYR Pharma announced today that the British Medicines and Healthcare products Regulatory Agency (MHRA) has issued the Promising Innovative Medicine (PIM) designation for [...]

Published
2019

15. Absorption Systems' ACF Bioservices Certified by European Agency for GMP-compliant Alternative Therapeutic Medicinal Product Stability and Product Release Testing

Subjects
Independent regulatory commissions -- Health aspects, Business, News, opinion and commentary, European Union
Abstract

EXTON, Pa., Aug. 7, 2018 /PRNewswire/ -- Absorption Systems and its ACF Bioservices(TM) subsidiary announced that they have been certified by the European Medicines and Healthcare products Regulatory Agency (MHRA). [...]

Published
2018

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