US FDA Proposes Tissue Biopsies in Clinical Trials

The US Food and Drug Administration (FDA) released a draft guidance in collaboration with the Office for Human Research Protections that, once finalized, will offer suggestions for incorporating tissue biopsies into clinical trials. The draft...

Adcentrx Commences Phase 1a/b Trial for Solid Tumor Therapy

Adcentrx Therapeutics (Adcentrx), a biotechnology company in clinical development focused on pioneering protein conjugates for cancer and other serious diseases, announced that the first patient has been dosed in the phase 1a/b trial of ADRX-0405...

Lupin Secures US FDA Nod for Pithampur manufacturing facility

Pharmaceutical firm Lupin Ltd has stated that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Pithampur Unit-1 manufacturing facility, which produces both APIs and...

Novo Nordisk and Valo Health Partner to develop novel Treatments

Novo Nordisk A/S and Valo Health, Inc. announced they have established a broader agreement to research and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease, utilizing Valo’s vast human dataset and AI-driven...

Vividion Therapeutics Acquires Tavros Therapeutics

Vividion Therapeutics, Inc., a clinical-stage biopharmaceutical firm leveraging innovative discovery technologies to reveal high-value, traditionally undruggable targets and create small molecule precision therapeutics for severe cancers and...

US FDA Grants Priority Review to Dizal's Sunvozertinib NDA

Dizal, a biopharmaceutical firm dedicated to creating innovative therapies for cancer and immunological disorders, revealed that the U.S. Food and Drug Administration (FDA) has accepted and assigned priority review to the company's New Drug...

JCR Pharma & Modalis Validate Breakthrough CNS Gene Therapy Concept

JCR Pharmaceuticals Co., Ltd., a worldwide specialty pharmaceuticals firm, and Modalis Therapeutics Corporation, a leader in epigenetic medicine, have revealed that they have confirmed the preliminary proof of concept in a joint research programme...

Acurx Pharma Secures EMA Approval for Ibezapolstat Phase 3 Program

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical firm dedicated to creating a novel class of small molecule antibiotics for challenging bacterial infections, announced that it has obtained positive regulatory guidance from the EMA in...

India's Pharma Industry Targets $130 Billion by 2030 to Lead Healthcare

India's pharmaceutical industry plans to increase its size to over USD 120-130 billion by 2030, leveraging innovation to establish itself as the global healthcare guardian, according to Samir Mehta, president of the Indian Pharmaceutical Alliance...

Zydus Partners with CVS Caremark to Expand Access to Diabetes Treatments

Zydus Lifesciences Ltd announced that it has formed a partnership with CVS Caremark to include Zituvio, Zituvimet, and Zituvimet XR tablets, which are utilized for diabetes treatment, in the latter's standard formulary. Zydus Lifesciences Ltd...

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