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1127 News Found

Apotex to acquire Canadian Searchlight Pharma
News | April 02, 2024

Apotex to acquire Canadian Searchlight Pharma

Combination will create a Canadian Health Champion spanning generic, biosimilar and branded pharmaceuticals


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Dr Reddy's partners with Sanofi India to distribute vaccine brands in India
News | March 28, 2024

Dr Reddy's partners with Sanofi India to distribute vaccine brands in India

Under the arrangement, Dr. Reddy's will have exclusive rights to promote and distribute Sanofi's vaccine brands Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri, Adacel and Avaxim 80U


Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility
Drug Approval | March 16, 2024

Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility

The company is confident of addressing the concern raised by the USFDA


Briefs: Zydus Lifesciences and Rainbow Children's Medicare
News | March 11, 2024

Briefs: Zydus Lifesciences and Rainbow Children's Medicare

Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility


EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process