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Marksans Pharma Subsidiary Secures USFDA Approval for Loperamide Hydrochloride Tablets USP, 2 mg

Marksans Pharma Subsidiary Secures USFDA Approval for Loperamide Hydrochloride Tablets USP, 2 mg

Marksans Pharma's wholly owned subsidiary, Marksans Pharma Inc., has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride Tablets USP, 2 mg (OTC).

Market | 19/11/2025 | By Dineshwori 153

AbbVie Receives FDA Approval for EPKINLY Combo in Relapsed/Refractory Follicular Lymphoma

AbbVie Receives FDA Approval for EPKINLY Combo in Relapsed/Refractory Follicular Lymphoma

AbbVie has secured FDA approval for EPKINLY in combination with rituximab and lenalidomide (EPKINLY + R2), marking the first bispecific antibody combo therapy available for patients with relapsed or refractory follicular lymphoma after at least one prior systemic treatment.

Market | 19/11/2025 | By Dineshwori 177

Johnson & Johnson to Acquire Halda Therapeutics for USD 3.05 Billion

Johnson & Johnson to Acquire Halda Therapeutics for USD 3.05 Billion

Johnson & Johnson has struck a definitive agreement to acquire Halda Therapeutics, a clinical-stage biotech company, for USD 3.05 billion in cash. Halda is known for its proprietary RIPTAC™ platform, which enables the development of oral, precision cancer therapies.

Market | 18/11/2025 | By Darshana 167

Marksans Pharma's UK Arm Relonchem Receives UK MHRA Approval for Mefenamic Acid Tablets

Marksans Pharma's UK Arm Relonchem Receives UK MHRA Approval for Mefenamic Acid Tablets

Marksans Pharma announced that its wholly owned UK subsidiary, Relonchem, has received marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for mefenamic acid 250 mg and 500 mg film-coated tablets. The approval further expands Relonchem’s growing footprint in the UK generics market.

Market | 17/11/2025 | By Dineshwori 328

DOMINA and SOLIDA: New Generation of Tablet Presses from IMA Active

DOMINA and SOLIDA: New Generation of Tablet Presses from IMA Active

Let's take a look at a new generation of tablet presses from IMA Active, DOMINA and SOLIDA, which are poised to change the meaning of production in the pharmaceutical industry.

Market | 15/11/2025 | By Dineshwori 431

SCRI and Bristol Myers Squibb Expand Collaboration to Accelerate Patient Enrollment and Broaden Access to Innovative Cancer Research

SCRI and Bristol Myers Squibb Expand Collaboration to Accelerate Patient Enrollment and Broaden Access to Innovative Cancer Research

SCRI and Bristol Myers Squibb have expanded their collaboration to accelerate patient enrollment and extend access to advanced cancer clinical trials. By leveraging a data-driven strategy, the partnership aims to bring innovative research opportunities to a broader range of communities.

Market | 15/11/2025 | By Dineshwori 180

CPHI & PMEC India 2025: Romaco to Launch Noack N 950E Blister Packaging Machine with India-made Format Parts

CPHI & PMEC India 2025: Romaco to Launch Noack N 950E Blister Packaging Machine with India-made Format Parts

German-based pharmaceutical machinery manufacturer Romaco is expanding its footprint in India with the localisation of format part production for its Noack 900 blister packaging machine series.

Market | 15/11/2025 | By Dineshwori 216

Zydus Receives Final Approval from USFDA for Leuprolide Acetate Injection

Zydus Receives Final Approval from USFDA for Leuprolide Acetate Injection

Zydus has secured final USFDA approval for its Leuprolide Acetate injection, a multiple-dose formulation indicated for the palliative treatment of advanced prostate cancer.

Market | 15/11/2025 | By Dineshwori 197

Transition Bio and Voyager Therapeutics Partner to Advance TDP-43 Small-Molecule Therapies for ALS and FTD

Transition Bio and Voyager Therapeutics Partner to Advance TDP-43 Small-Molecule Therapies for ALS and FTD

Under the terms of the partnership, Transition Bio is responsible for the discovery and optimisation of small molecules targeting TDP-43 until nomination of a development candidate, upon which Voyager will have an option to license the worldwide exclusive rights to develop and commercialise the programme.

Market | 15/11/2025 | By Dineshwori 319

FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer

FDA Approves Diagnostic Tool for Pembrolizumab Combo in Endometrial Cancer

The US FDA has cleared the OncoMate MSI Dx Analysis System as a companion diagnostic to guide pembrolizumab-based combination therapy in advanced endometrial cancer. The PCR-based assay determines microsatellite instability (MSI) status in tumour tissue, with support from Merck, developer of pembrolizumab and lenvatinib.

Market | 15/11/2025 | By Dineshwori 322

 
 

 

 

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