News about Drug Discovery & Development

Hinova Pharma Secures FDA Fast Track Designation for HP518

Hinova Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC).

Drug Discovery & Development | 08/07/2024 | By Aishwarya |  821

Alembic Pharma Gets Tentative Approval from FDA for Ivosidenib Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg.

Drug Discovery & Development | 05/07/2024 | By Aishwarya |  629

Aurigene and Edity to Partner in Cell Therapy

Aurigene Pharmaceutical Services Ltd. has announced that it will provide discovery services to Edity Therapeutics in cell therapy.

Drug Discovery & Development | 03/07/2024 | By Aishwarya |  759

EMA Accepts Approval for AstraZeneca MAA for Sipavibart

AstraZeneca has announced that its Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.

Drug Discovery & Development | 02/07/2024 | By Aishwarya |  730

Alembic Pharma Secures USFDA Tentative Approval for Bosutinib Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets, 100 mg and 500 mg.

Drug Discovery & Development | 02/07/2024 | By Aishwarya |  1022

Avantor Launches Two New J.T.Baker Cell Lysis Solution and J.T.Baker Endonuclease

Avantor, Inc. announced the launch of two innovative products that together sustainably optimize the gene therapy harvest process: J.T.Baker® Cell Lysis Solution and J.T.Baker® Endonuclease.

Drug Discovery & Development | 01/07/2024 | By Manvi |  523

Alembic Pharmaceuticals Secures FDA Final Approval for Doxycycline Capsules

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg.

Drug Discovery & Development | 29/06/2024 | By Aishwarya |  441

Lupin Gets Tentative Approval from FDA for Olopatadine Hydrochloride Ophthalmic Solution

Lupin has received a tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent (OTC).

Drug Discovery & Development | 28/06/2024 | By Aishwarya |  770

WACKER & CordenPharma Enter Pandemic Readiness State for Germany

WACKER and CordenPharma have officially entered the pandemic readiness state as of June 1, 2024.

Drug Discovery & Development | 25/06/2024 | By Aishwarya |  388

Ethypharm Signs Deal with MTPC to Acquire Argatroban Monohydrate

Ethypharm has signed an agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) to acquire the selective antithrombin agent, Argatroban monohydrate (Argatra, Arganova, Novastan, Exembol), in Europe.

Drug Discovery & Development | 18/06/2024 | By Aishwarya |  1036