Tag archive for ‘US Food and Drug Administration’
Bristol Myers Squibb, bluebird bio bag Abecma FDA approval for multiple myeloma in adults
By businessnewstoday On Sunday, March 28th, 2021
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BMS, bluebird bio bag Abecma FDA approval for multiple myeloma in adults

(adsbygoogle = window.adsbygoogle || []).push({}); Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food and Drug Administration (FDA) for Abecma More...

FDA accepts Airway Therapeutics’ IND for bronchopulmonary dysplasia treatment candidate AT-100 in preterm infants
By businessnewstoday On Saturday, March 27th, 2021
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FDA accepts Airway’s IND for AT-100 for bronchopulmonary dysplasia treatment in preterm infants

Bronchopulmonary dysplasia treatment : Airway Therapeutics said that the US Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for developing AT-100 (rhSP-D) as a preventive More...

Anixa Biosciences files IND with FDA for ovarian cancer CAR-T therapy
By businessnewstoday On Monday, March 22nd, 2021
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Anixa Biosciences files IND with FDA for ovarian cancer CAR-T therapy

Anixa Biosciences said that it has filed an investigational new drug (IND) application for its ovarian cancer CAR-T therapy with the US Food and Drug Administration (FDA). The ovarian cancer CAR-T therapy was invented More...

Precigen gets FDA orphan drug status for PRGN-2012 in recurrent respiratory papillomatosis
By businessnewstoday On Thursday, March 18th, 2021
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Precigen gets FDA orphan drug status for PRGN-2012 in RRP

Precigen has secured orphan drug designation (ODD) for PRGN-2012 from the US Food and Drug Administration (FDA) in recurrent respiratory papillomatosis (RRP). PRGN-2012 is an investigational off-the-shelf (OTS) More...

Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205
By businessnewstoday On Tuesday, March 16th, 2021
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Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205

Cytocom has secured clearance from the US Food and Drug Administration (FDA) to undertake a phase 2 clinical trial of CYTO-205 for the treatment of Covid-19. The company’s investigational new drug (IND) application More...

J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization
By businessnewstoday On Sunday, February 28th, 2021
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J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization

Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine developed by its subsidiary Janssen More...

MSCP wraps up $330m sale of majority stake in Hojeij Branded Foods to Lagardere
By pharmanewsdaily On Monday, February 15th, 2021
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G1 Therapeutics gets Cosela FDA approval to reduce chemotherapy-induced bone marrow suppression

G1 Therapeutics has bagged approval for Cosela (trilaciclib) from the US Food and Drug Administration (FDA) for reducing bone marrow suppression caused by chemotherapy. Cosela FDA approval is for its use in cutting More...

By pharmanewsdaily On Monday, February 15th, 2021
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Targovax gets FDA fast track status for ONCOS-102 in malignant pleural mesothelioma

Targovax, a Norwegian immune-oncology company, said that its lead candidate ONCOS-102 has secured the fast track designation from the US Food and Drug Administration (FDA) for malignant pleural mesothelioma. The More...

MSCP wraps up $330m sale of majority stake in Hojeij Branded Foods to Lagardere
By pharmanewsdaily On Monday, February 15th, 2021
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G1 Therapeutics gets Cosela FDA approval to reduce chemotherapy-induced bone marrow suppression

G1 Therapeutics has bagged approval for Cosela (trilaciclib) from the US Food and Drug Administration (FDA) for reducing bone marrow suppression caused by chemotherapy. Cosela FDA approval is for its use in cutting More...

MSCP wraps up $330m sale of majority stake in Hojeij Branded Foods to Lagardere
By pharmanewsdaily On Monday, February 15th, 2021
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Targovax gets FDA fast track status for ONCOS-102 in malignant pleural mesothelioma

Targovax, a Norwegian immune-oncology company, said that its lead candidate ONCOS-102 has secured the fast track designation from the US Food and Drug Administration (FDA) for malignant pleural mesothelioma. The More...