Biopharma

Argenx stays on a roll with Vyvgart, gaining FDA nod fo...

Already thriving with a successful launch of infused Vyvgart and its subcutaneou...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Cinqaero, reslizumab, ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Edurant, rilpivirine, ...

As Pfizer backs out of hemophilia gene therapy space, C...

After Pfizer let limited patient interest get the best of its hemophilia B gene ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Effentora, fentanyl, D...

Market volatility compounds ‘already challenging’ year ...

The market turbulence unleashed by President Donald Trump’s tariff policies will...

Fierce Pharma Asia—Congress' US-China biotech report; N...

A special congressional committee has recommended a $15 billion investment to bo...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Fabhalta, Iptacopan, D...

As work on massive US plant continues, Kyowa Kirin wrap...

As work continues on a new biologics plant in the U.S., Kyowa Kirin has complete...

Template for the qualified person's (QP) declaration co...

Template for the qualified person's (QP) declaration concerning good manufacturi...

RFK Jr. has yet another theory about vaccines

In today's Morning Rounds newsletter, RFK Jr.'s latest theory about vaccines, ho...

Questions & answers - Practical arrangements on the com...

Questions & answers - Practical arrangements on the companion diagnostics consul...

Overview of NCAs participating in the voluntary Simulta...

Overview of NCAs participating in the voluntary Simultaneous National Scientific...

Questions & answers - Practical arrangements on the com...

Questions & answers - Practical arrangements on the companion diagnostics consul...

COVID-19 vaccines: key facts

COVID-19 vaccines: key facts

STAT+: Pharmalittle: We’re reading about FDA drug revie...

While FDA drug and device reviewers and inspectors were protected from layoffs, ...

Q1 biopharma layoff trends, plus expectations for Q2

In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and F...

PhRMA calls out insurers that own PBMs, pharmacies in n...

PhRMA's latest ad highlights the double trouble that can come from pharmacy bene...

Opinion on medicine for use outside EU: Aluvia, lopinav...

Opinion on medicine for use outside EU: Aluvia, lopinavir,ritonavir, HIV Infecti...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Xermelo, telotristat e...

Veterinary medicines European public assessment report ...

Veterinary medicines European public assessment report (EPAR): Nobilis Multriva ...

Veterinary medicines European public assessment report ...

Veterinary medicines European public assessment report (EPAR): Nobilis Multriva ...

Veterinary medicines European public assessment report ...

Veterinary medicines European public assessment report (EPAR): Emevet, maropitan...

Meeting highlights from the Committee for Veterinary Me...

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus...

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