Biopharma

FDA reviews Novo Nordisk's bid to expand Rybelsus as oral GLP-1 cuts heart disease risks

FDA reviews Novo Nordisk's bid to expand Rybelsus as or...

Mar 31, 2025 0

The FDA has accepted Novo Nordisk's application for a label expansion for oral G...

Judge levies $1.64B penalty on Johnson & Johnson in HIV drug marketing case

Judge levies $1.64B penalty on Johnson & Johnson in HIV...

Mar 31, 2025 0

Nearly a year after a jury decided that Johnson & Johnson should be fined just o...

Human medicines European public assessment report (EPAR): Giotrif, afatinib, Date of authorisation: 25/09/2013, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Giotrif, afatinib, Dat...

Corcept's investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing

Corcept's investigational oral therapy cuts ovarian can...

Mar 31, 2025 0

Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ...

As FDA's Peter Marks resigns, industry watchers size up vaccine, cell and gene therapy hits

As FDA's Peter Marks resigns, industry watchers size up...

Mar 31, 2025 0

In resigning as director of the FDA’s Center for Biologics Evaluation and Resear...

GE HealthCare unveils cardiac-focused CT scanner, launches coronary radiotracer

GE HealthCare unveils cardiac-focused CT scanner, launc...

Mar 31, 2025 0

The Revolution Vibe scanner includes what the company describes as unlimited one...

Human medicines European public assessment report (EPAR): Locametz, gozetotide, Date of authorisation: 09/12/2022, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Locametz, gozetotide, ...

As FDA's Peter Marks resigns, industry watchers eye vaccine, cell and gene therapy hits

As FDA's Peter Marks resigns, industry watchers eye vac...

Mar 31, 2025 0

In resigning as director of the FDA’s Center for Biologics Evaluation and Resear...

Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Date of authorisation: 21/04/2009, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepi...

Google DeepMind’s drug discovery spin-off Isomorphic Labs raises $600mn

Google DeepMind’s drug discovery spin-off Isomorphic La...

Mar 31, 2025 0

AI unit is boosted by first external funding round led by OpenAI-backer Thrive C...

Corcept’s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing

Corcept’s investigational oral therapy cuts ovarian can...

Mar 31, 2025 0

Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ...

Concept paper on the revision of the guideline on the S...

Mar 31, 2025 0

Concept paper on the revision of the guideline on the Scientific Data Requiremen...

Scientific data requirements for plasma master file - Scientific guideline

Scientific data requirements for plasma master file - S...

Mar 31, 2025 0

Scientific data requirements for plasma master file - Scientific guideline

Apollomics hands Asia rights to its lead c-MET inhibitor to Taiwan’s LaunXP in $60M deal

Apollomics hands Asia rights to its lead c-MET inhibito...

Mar 31, 2025 0

Apollomics has sold the rights to its lead c-MET inhibitor in Asia, excluding Gr...

Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline

Development of a guideline on the quality aspects of mR...

Mar 31, 2025 0

Development of a guideline on the quality aspects of mRNA vaccines - Scientific ...

Draft guideline on the quality aspects of mRNA vaccines

Mar 31, 2025 0

Draft guideline on the quality aspects of mRNA vaccines

Alphabet's AI biotech Isomorphic Labs hauls in $600M to power next-gen drug design model

Alphabet's AI biotech Isomorphic Labs hauls in $600M to...

Mar 31, 2025 0

AI drug discovery firm Isomorphic Labs has completed the company’s first externa...

Draft Reflection paper on linking to electronic product...

Mar 31, 2025 0

Draft Reflection paper on linking to electronic product information (ePI) from E...

Electronic product information (ePI)

Electronic product information (ePI)

Mar 31, 2025 0

Electronic product information (ePI)

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of authorisation: 18/01/2021, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab d...

'It's just ugly': Federal funding cuts to Columbia University leave chronic fatigue syndrome research in limbo

'It's just ugly': Federal funding cuts to Columbia Univ...

Mar 31, 2025 0

Earlier this month, Ian Lipkin, M.D., and his team at Columbia University submit...

Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Date of authorisation: 21/03/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Amgevita, adalimumab, ...

Merck's Winrevair slashes mortality-morbidity risk by 76%

Merck's Winrevair slashes mortality-morbidity risk by 76%

Mar 31, 2025 0

Merck revealed data from a phase 3 study of pulmonary arterial hypertension drug...

Human medicines European public assessment report (EPAR): MicardisPlus, Date of authorisation: 19/04/2002, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): MicardisPlus, Date of ...

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