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Results For "regulatory-filing"

90 News Found

OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection
News | May 04, 2026

OneSource Specialty Pharma's partners get Health Canada approval for generic Semaglutide injection

Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing


Teva strikes $900M bet on breakthrough Tourette drug with Emalex buyout
News | April 30, 2026

Teva strikes $900M bet on breakthrough Tourette drug with Emalex buyout

The agreement could rise to $900 million if key commercial milestones are met


Lupin subsidiary settles US antitrust case with Humana for $30 Million
News | April 20, 2026

Lupin subsidiary settles US antitrust case with Humana for $30 Million

The litigation involved multiple civil lawsuits alleging anti-competitive practices and violations of federal


Cipla receives two observations following USFDA inspection at Goa facility
Drug Approval | April 18, 2026

Cipla receives two observations following USFDA inspection at Goa facility

The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe


Orchid Pharma submits Q4 FY26 SEBI compliance certificate to NSE, BSE
News | April 11, 2026

Orchid Pharma submits Q4 FY26 SEBI compliance certificate to NSE, BSE

Routine regulatory filing confirms completion of demat and share transfer compliances for March quarter


Merck moves to seal $53-a-share takeover of Terns Pharmaceuticals
News | April 08, 2026

Merck moves to seal $53-a-share takeover of Terns Pharmaceuticals

The acquisition aims to bolster Merck’s hematology portfolio with Terns’ lead oncology candidate, TERN-701


HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets
News | April 07, 2026

HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets

Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets


Concord Biotech acquires Celliimune to accelerate DNA-engineered cancer therapies
Biotech | April 04, 2026

Concord Biotech acquires Celliimune to accelerate DNA-engineered cancer therapies

Rs 66 lakh acquisition will support DNA engineering and novel cell-gene therapy alternatives to conventional chemotherapy


Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma
Biotech | April 04, 2026

Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma

The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy


Bayer wins world-first nod in Japan for low-dose MRI contrast agent
News | March 24, 2026

Bayer wins world-first nod in Japan for low-dose MRI contrast agent

Call it a major breakthrough for diagnostic imaging