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...
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...
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...
The Subject Expert Committee (SEC) operating under the Central Drug Standard Control Organisation (CDSCO) has permitted drug giant Sun Pharma Laboratories to produce and sell Fexuprazan Hydrochloride Tablets 40 mg. Nonetheless, this approval is...
Innovent Biologics, a top-tier biopharmaceutical firm focused on creating, producing, and marketing high-quality drugs for oncology, cardiovascular and metabolic diseases, autoimmune disorders, ophthalmology, and various other serious illnesses...
Akums Drugs and Pharmaceuticals revealed the launch of a new sterile facility focused on manufacturing lyophilised products and injectables, alongside vials, ampoules, eye and ear drops, and form-fill-seal (FFS) products. Lyophilisation involves...
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...
India now represents 60% of worldwide vaccine production and hosts the second-highest number of USFDA-approved manufacturing facilities outside the United States. As investment prospects expand in areas like Bio-Pharma, Bio-Agri, Bio-Industrial...
According to recent data, 54% of advanced biotech laboratories have identified gene-editing research as their main growth engine this year, highlighting the increasing importance of this sector. The worldwide gene therapy market had a valuation of...
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...
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