Bayer Bolsters India Focus with Expanded Therapies and Healthcare Ecosystem

German multinational pharmaceutical and biotechnology firm Bayer aims to bolster its presence in India by broadening its range of therapies and increasing collaborations throughout the healthcare ecosystem. Bayer has launched various treatments to...

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...

Hanx Biopharma Starts Patient dosing Phase 1 Trial of HX044

Hanx Biopharma, Inc. Ltd, a pioneering biotechnology firm focused on creating next-generation immunotherapies to tackle the challenges posed by unmet medical needs, announced the first patient dosing in Australia on December 30, 2024, for the...

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...

Sun Pharma Bags CDSCO Approval to Produce Fexuprazan Hydrochloride Tablets

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 and Roche Partner to Advance Novel DLL3-Targeted ADC, IBI3009

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 Unveils New Sterile Facility for Lyophilised Products and Injectables

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 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...

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