Biopharma

Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma, rivastigmine, Date of authorisation: 11/12/2009, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharm...

Chutes & Ladders—FDA rocked by leadership shake-ups

Chutes & Ladders—FDA rocked by leadership shake-ups

Apr 4, 2025 0

As the Department of Health and Human Services grapples with the fallout of mass...

Fierce Pharma Asia—Pharma CEOs meet Xi Jinping; Trump's tariffs; BioNTech's bispecific data

Fierce Pharma Asia—Pharma CEOs meet Xi Jinping; Trump's...

Apr 4, 2025 0

Several pharma CEOs met with Chinese President Xi Jinping in Beijing. Donald Tru...

How the Trump administration will fight drug overdoses

How the Trump administration will fight drug overdoses

Apr 4, 2025 0

And more of the latest health news stories of the day.

Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2025 Positive

Orphan designation: bexmarilimab Treatment of myelodysp...

Apr 4, 2025 0

Orphan designation: bexmarilimab Treatment of myelodysplastic syndromes, 25/03/2...

Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan, sitagliptin hydrochloride monohydrate,metformin hydrochloride, Date of authorisation: 16/02/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Sitagliptin / Metformi...

Orphan designation: ixodes ricinus contact phase inhibitor Treatment of non-traumatic spontaneous intracerebral haemorrhage, 25/03/2025 Positive

Orphan designation: ixodes ricinus contact phase inhibi...

Apr 4, 2025 0

Orphan designation: ixodes ricinus contact phase inhibitor Treatment of non-trau...

Apollomics tags out of TYG oncology pact to cut costs, extend runway into 2026

Apollomics tags out of TYG oncology pact to cut costs, ...

Apr 4, 2025 0

Apollomics has tagged out of its partnership with TYG Oncology, terminating an i...

M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals

M&A recap: Big pharma starts the year mostly avoiding b...

Apr 4, 2025 0

Just two acquisitions in the first quarter, that of Intra-Cellular Therapies and...

Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Date of authorisation: 26/07/2018, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole,...

Orphan designation: Felzartamab Treatment of in solid organ transplantation, 13/12/2024 Positive

Orphan designation: Felzartamab Treatment of in solid o...

Apr 4, 2025 0

Orphan designation: Felzartamab Treatment of in solid organ transplantation, 13/...

Orphan designation: deucrictibant monohydrate Treatment of bradykinin-mediated angioedema, 25/03/2025 Positive

Orphan designation: deucrictibant monohydrate Treatment...

Apr 4, 2025 0

Orphan designation: deucrictibant monohydrate Treatment of bradykinin-mediated a...

Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains Treatment of multiple myeloma, 04/06/2020 Withdrawn

Orphan designation: Autologous T lymphocyte-enriched po...

Apr 4, 2025 0

Orphan designation: Autologous T lymphocyte-enriched population of cells transdu...

Shuren on FDA's future: 'Where do we go from here? ... Who knows?'

Shuren on FDA's future: 'Where do we go from here? ... ...

Apr 4, 2025 0

In a webinar hosted by the medtech development service provider NAMSA, the forme...

FDA's chief medical officer Hilary Marston is out amid mass layoffs

FDA's chief medical officer Hilary Marston is out amid ...

Apr 4, 2025 0

The FDA’s Chief Medical Officer Hilary Marston, M.D., is leaving her position at...

Human medicines European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord, vildagliptin / metformin hydrochloride, Date of authorisation: 24/03/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Vildagliptin / Metform...

Human medicines European public assessment report (EPAR): Reblozyl, luspatercept, Date of authorisation: 25/06/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Reblozyl, luspatercept...

European Medicines Agency guidance for applicants seeki...

Apr 4, 2025 0

European Medicines Agency guidance for applicants seeking scientific advice and ...

Science panel’s advice for next dietary guidelines could be on collision course with MAHA

Science panel’s advice for next dietary guidelines coul...

Apr 4, 2025 0

The Dietary Guidelines for America are due by the end of the year, but Trump adm...

Opinion: FDA cuts may mean even less oversight of pet food

Opinion: FDA cuts may mean even less oversight of pet food

Apr 4, 2025 0

The system regulating pet food in the U.S. is patchy — and getting more so.

Opinion: The body of public health is taking two destructive hits at once

Opinion: The body of public health is taking two destru...

Apr 4, 2025 0

Cuts to federal programs that have long-standing roles in public protection have...

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

FDA Grants Accelerated Approval for Vanrafia (atrasenta...

Apr 4, 2025 0

Basel, April 3, 2025 – Novartis today announced the US Food and Drug Administrat...

STAT+: Federal advisory panel on ethical, legal issues in human health research disbanded

STAT+: Federal advisory panel on ethical, legal issues ...

Apr 4, 2025 0

A committee of experts that advises HHS on emerging ethical and legal issues in ...

Eli Lilly helps struggling Sangamo with $1.4B gene therapy deal

Eli Lilly helps struggling Sangamo with $1.4B gene ther...

Apr 3, 2025 0

Sangamo Therapeutics has secured a licensing deal with Eli Lilly that helps exte...

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