Drug Approval | March 31, 2026
Teva hits major biosimilar milestones with FDA nod and regulatory filings
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
Company plans to appeal against CGST order related to alleged inadmissible input tax credit claims
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing
The agreement could rise to $900 million if key commercial milestones are met
The litigation involved multiple civil lawsuits alleging anti-competitive practices and violations of federal
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
Routine regulatory filing confirms completion of demat and share transfer compliances for March quarter
The acquisition aims to bolster Merck’s hematology portfolio with Terns’ lead oncology candidate, TERN-701
Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets
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