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...

Astella's Vyloy Approved in China for HER2-Negative Gastric Cancer

Astellas Pharma Inc. announced that China’s National Medical Products Administration (NMPA) has given the approval to Vyloy (zolbetuximab), in conjunction with fluoropyrimidine- and platinum-based chemotherapy, for the initial treatment of...

NMD Pharma Receives US FDA Orphan Drug Designation for NMD670 in CMT

NMD Pharma A/S, a biotech firm in the clinical stage focused on creating innovative and enhanced therapies for individuals with neuromuscular disorders, revealed that the U.S. Food and Drug Administration (FDA) has awarded orphan drug designation...

Capricor Therapeutics Submits BLA for FDA Approval of Deramiocel in DMD

Capricor Therapeutics, a biotech firm focused on developing innovative cell and exosome-based therapies for rare diseases, has announced the completion of the submission of its Biologics License Application (BLA) to the US Food and Drug...

Centre Extends GMP Compliance Deadline for Small Pharma Firms

The Centre intends to extend the deadline for complying with good manufacturing practice (GMP), aligned with World Health Organization (WHO) standards, for small pharmaceutical firms earning ?250 crore or below by one year to 31 December 2025...

CDSCO Approves Miqnaf as new Treatment for CABP

The Indian drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), has authorized Miqnaf (nafithromycin) as a new treatment for Community-Acquired Bacterial Pneumonia (CABP) in adults. Miqnaf is a rapid, three-day treatment...

Biocon Pharma Secures NMPA Approval for Tacrolimus Capsules in China

Biocon Pharma Ltd has secured approval from China's National Medical Products Administration (NMPA) for its Tacrolimus capsules available in 0.5mg, 1mg, and 5mg dosages. Tacrolimus, an immunosuppressive medication, is utilized to inhibit organ...

USFDA Approves NDA for Avutometinib-Defactinib Combo in KRAS-Mutated Cancer

Verastem Oncology, a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated...

USFDA Approves Pfizer's BRAFTOVI Combo for BRAF V600E mCRC

Pfizer Inc revealed that the US Food and Drug Administration (FDA) has authorized BRAFTOVI (encorafenib) alongside cetuximab (sold as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for treating patients with metastatic...

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