Biopharma

Remote blood sample collector maker YourBio Health reva...

The Flagship Pioneering portfolio company appointed Paul Owen as its CEO last ye...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Apretude, cabotegravir...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin ...

Clinical Trial Information System (CTIS) - Sponsor hand...

Clinical Trial Information System (CTIS) - Sponsor handbook

Radiance rolls into ROR1 race, paying $15M for ADC riva...

Radiance Biopharma is heating up the ROR1 race. The U.S. biotech is paying China...

Merck pens $300M-per-product collab with Epitopea to lo...

Merck & Co. has penned a $300 million biobucks-per-product deal with cancer biot...

Options shrink for Supernus depression drug candidate a...

Supernus Pharmaceuticals may have had a potential path forward for its depressio...

FDA's clinical trial diversity guidance carries new mes...

While the FDA’s diversity guidance for clinical trials has been temporarily rest...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Nemluvio, nemolizumab,...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacteri...

Assessment templates and guidance

Assessment templates and guidance

Generic and hybrid applications

Generic and hybrid applications

Biosimilar medicines: marketing authorisation

Biosimilar medicines: marketing authorisation

Opinion: The Kansas City TB outbreak shows the value of...

The tuberculosis outbreak in the Kansas City area is not, in fact, the largest i...

STAT+: The ‘GRAS’ loophole lets untested additives into...

RFK Jr. wants to tackle the GRAS exemption, which allows companies to put chemic...

Opinion: STAT+: Recursion CEO: Publicly funded research...

If policymakers fail to act swiftly to restore medical research funding, then it...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Da...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Blenrep, belantamab ma...

Orphan designation: Humanised monoclonal antibody targe...

Orphan designation: Humanised monoclonal antibody targeting B-cell maturation an...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Galvus, vildagliptin, ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Da...

Type-IA variations: questions and answers

Type-IA variations: questions and answers

FDA’s clinical trial diversity guidance carries new mes...

While the FDA’s diversity guidance for clinical trials has been temporarily rest...

The copycat brands that are replacing Ozempic in Russia

Local pharma groups have taken over a lucrative niche market

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