Biopharma

Minutes of the PRAC meeting 13-16 May 2024

Minutes of the PRAC meeting 13-16 May 2024

Vaccine-probiotic combo prevents, clears bacterial gut ...

Researchers combined a vaccine and a probiotic supplement to tend the microbial ...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Quinsair, levofloxacin...

Orphan designation: imetelstat sodium Treatment of myel...

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27...

Emergency Task Force (ETF) documents

Emergency Task Force (ETF) documents

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Rasagiline ratiopharm,...

ICH Guideline M13B on bioequivalence for immediate rele...

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage for...

ICH Guideline M13B on bioequivalence for immediate-rele...

ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage for...

STAT+: Debate over soda, candy bans shows how MAHA is s...

Low-income Americans could soon have new constraints on how they shop for food u...

STAT+: AI agents in health care: Everything you need to...

AI agents are finding their way into the world of health care, but tech develope...

Opinion: AI scribe technology lets me focus on my patie...

“Having an AI scribe means I have more quality time with my patients,” writes ph...

Opinion: The invisibility of good public health work

“There is a mission to do”: How two local public health officials are tackling t...

Public health leaders, besieged and regretful, talk of ...

Public health leaders met to celebrate the field but also to talk about regret a...

Orphan designation: Unesbulin Treatment of soft tissue ...

Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withd...

Orphan designation: Lactobacillus plantarum Treatment o...

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral scl...

Orphan designation: Alrefimotide acetate,riletamotide a...

Orphan designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acet...

Orphan designation: Glofitamab Treatment of diffuse lar...

Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10...

Former CBER head Peter Marks says he blocked RFK Jr. fr...

Peter Marks, M.D., Ph.D., the former director of the Center for Biologics Evalua...

HHS cuts contract spend by 35%, with 334 pacts already ...

In the latest of a string of clawbacks, the Department of Health and Human Servi...

STAT+: HHS firings could face legal challenges over ina...

A week after widespread cuts at the Department of Health and Human Services, man...

Worldwide Clinical Trials turns to AI company to identi...

Global CRO Worldwide Clinical Trials has enlisted AI tech firm NetraMark to disc...

Regulatory tracker: BMS' Opdivo plus Yervoy snags FDA n...

In this tracker, Fierce Pharma is recording the regulatory progress of in-market...

NIH blocks researchers in China, Russia and other count...

The Trump administration has blocked access to multiple data repositories mainta...

Stroke tech developers Kandu, Neurolutions combine with...

The revamped Kandu will move forward with $30 million in new financing, through ...

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