Biopharma

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Skilarence, dimethyl f...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Cejemly, sugemalimab, ...

Merck plots 163 layoffs as it prepares to shutter Penns...

The company revealed a plan to shutter the site back in March of 2022. Now, more...

European Organisation for Research and Treatment of Can...

European Organisation for Research and Treatment of Cancer (EORTC) bilateral mee...

Fierce Biotech Fundraising Tracker '25: Latigo whips up...

The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 mil...

Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, cit...

A trio of drugmakers have issued separate recalls in the U.S. thanks to string o...

Avanos taps Siemens Healthineers’ Americas president as...

David Pacitti is leaving the imaging giant to become CEO of Avanos Medical, afte...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Lazcluze, lazertinib, ...

Orca Bio to seek approval of T cell transplant after po...

Study results showed Orca’s treatment, a purified mix of donor-derived T cells a...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Yervoy, ipilimumab, Da...

EMEA-003389-PIP01-23

EMEA-003389-PIP01-23

Curevo rounds up $110M to challenge GSK’s Shringrix, na...

In its effort to rival GSK’s shingles vaccine Shingrix, Curevo Vaccine has circl...

Methylphenidate product-specific bioequivelance guidance

Methylphenidate product-specific bioequivelance guidance

2024-2026 Work Plan of the Good Clinical Practice Inspe...

2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP ...

AstraZeneca signs Alteogen deal worth up to $1.35B for ...

AstraZeneca has signed two deals worth $1.35 billion with Alteogen to developmen...

FDA warns hemodialysis tubing shortage could continue i...

The FDA is urging dialysis providers to conserve their supplies of blood flow li...

Novo Nordisk accepted back into UK pharma group after ‘...

Novo Nordisk has been accepted back into the fold. Two years after suspending No...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Uptravi, selexipag, Da...

EMEA-002951-PIP02-21

EMEA-002951-PIP02-21

STAT+: After a big donor sought care from a Dana-Farber...

How a case involving Dana-Farber Cancer Institute illustrates the potential risk...

STAT+: Oz’s Medicare pledges, and federal watchdogs dro...

This week in health care business news: Dr. Oz will scrutinize Medicare Advantag...

Opko, Entera share ownership of first oral GLP-1/glucag...

Opko Health and Entera Bio have formalized their partnership as the biotechs pre...

Regulatory tracker: Bayer picks up FDA priority review ...

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

Opinion/decision on a Paediatric investigation plan (PI...

Opinion/decision on a Paediatric investigation plan (PIP): Vabysmo, Faricimab, d...

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