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Mabwell Advances ADC Manufacturing Pipeline With NMPA-Backed Combination Trial Approval
Mabwell, an innovation-driven biopharmaceutical company with fully integrated capabilities spanning research and development, manufacturing, and commercialisation, announced that China’s National Medical Products Administration (NMPA) has approved the initiation of clinical trials for its independently developed B7-H3–targeting antibody–drug conjugate.
India’s pharmaceutical export industry is preparing for 2026 with a sharp focus on quality excellence, regulatory compliance and diversification into new global markets, according to the Pharmaceuticals Export Promotion Council of India (Pharmexcil).
EMA Grants Accelerated Assessment to WCK 5222 by Wockhardt
The European Medicines Agency (EMA) has granted Accelerated Assessment status to Wockhardt’s WCK 5222, a fixed-dose combination of zidebactam and cefepime, following a pre-submission meeting—potentially enabling a faster regulatory review of the novel antibiotic therapy.
Outlook Therapeutics Updates FDA Review of ONS-5010/LYTENAVA for Wet AMD
Outlook Therapeutics has provided an update on the U.S. Food and Drug Administration’s review of its resubmitted Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration, following the FDA’s issuance of a Complete Response Letter (CRL).
Valneva and Serum Institute End Chikungunya Vaccine Licensing Deal
Valneva SE and the Serum Institute of India have mutually agreed to discontinue their licensing agreement for Valneva’s single-shot chikungunya vaccine, bringing the collaboration to a close by mutual consent.
Government Proposes Amendment to Make Cough Syrups Prescription-Only Drugs
The Union Health Ministry has issued a draft amendment to the Drugs Rules, 1945, proposing to remove cough syrups from Schedule K—a move that would end their Over-the-Counter (OTC) availability and mandate prescription-only sales in the interest of public safety.
XORTX Unveils New Research on Genome-Wide Pathways in Gout
XORTX Therapeutics highlighted findings from recent independent, peer-reviewed research showing that multiple genetic factors are linked to over-expression of Xanthine Oxidase (XO), chronically elevated blood uric acid levels, and gout—further reinforcing the company’s strategy of targeting XO to treat gout, kidney, and related diseases.
Mabwell Adalimumab Biosimilar Wins Marketing Approval in Indonesia
Mabwell’s adalimumab biosimilar 9MW0113, co-developed with Junshi Biosciences, has received marketing approval from Indonesia’s BPOM, becoming the first China-developed adalimumab biosimilar to secure such approval, as the company advances global expansion with partnerships in over 10 countries.
A New Year, A New Chapter for Pharma Manufacturing in India
As India steps into a new year, the pharmaceutical manufacturing sector stands at a defining crossroads. Over the past few years, Indian pharma has moved far beyond its traditional identity as the “pharmacy of the world” for generics.
StimLabs Secures FDA 510(k) Clearance for Umbilical Cord-Derived Wound Care Sheet Device
StimLabs, a regenerative medicine company focused on advancing wound care solutions, has received 510(k) clearance from the US Food and Drug Administration (FDA) for Theracor, the first human umbilical cord-derived medical device available in sheet form.
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