Biopharma

Cellares' cell therapy factory-in-a-box scores coveted ...

Cellares’ automated cell therapy production platform, known as the Cell Shuttle,...

Get ready for ‘Liberation Day’ (Trump’s tariff announce...

And more biotech news stories, brought to you by The Readout.

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim,...

STAT+: Pharmalittle: We’re reading about NIH directors ...

Directors of five NIH institutes have been placed on administrative leave or off...

Inside yesterday’s anxiety-inducing, ‘crude and callous...

Get your daily dose of health and medicine every weekday with STAT’s free newsle...

Inside yesterday’s anxiety-inducing, “crude and callous...

Get your daily dose of health and medicine every weekday with STAT’s free newsle...

Meeting of the Medicine Shortages Single Point of Conta...

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, ...

Sanofi taps Nurix for pipeline nourishment once again, ...

Sanofi has returned to Nurix Therapeutics for another autoimmune candidate, payi...

Edgewise claims heart valve pressure benefits in phase ...

Edgewise Therapeutics' hypertrophic cardiomyopathy asset has resulted in “rapid ...

Regulatory tracker: Apellis picks up FDA priority revie...

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

Joint HTAb-regulatory perspectives on understanding evi...

Joint HTAb-regulatory perspectives on understanding evidence challenges, managin...

Atsena raises $150M for ocular gene therapies with Bain...

Atsena Therapeutics has raised $150 million in an oversubscribed series C financ...

Patient suffers side effect in Cabaletta autoimmune CAR...

Analysts appeared unfazed by the news that a patient treated with Cabaletta Bio’...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): BroPair Spiromax, salm...

Biosimilar medicines: Overview

Biosimilar medicines: Overview

Federal judge blocks FDA's regulation of lab-developed ...

The ruling was issued for a pair of lawsuits brought against the FDA by the Amer...

STAT+: Vida Ventures brings in new leaders after co-fou...

Cell therapy veteran Arie Belldegrun is expanding his empire, bringing in two ne...

2 investment firms secure large stakes in Novotech

Two investment firms have acquired large stakes in global CRO Novotech, the Sing...

Tolvaptan product-specific bioequivalence guidance

Tolvaptan product-specific bioequivalence guidance

EMEA-000551-PIP04-21-M03

EMEA-000551-PIP04-21-M03

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

Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant...

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

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan me...

Opinion: Every doctor is a writer: On the end of note-w...

“As a doctor who is very much a writer, I feel a sense of dread and even grief a...

Opinion: A former HHS secretary’s fears for America’s f...

“If you just looked at the economics of this, vaccines are one of the few ways w...

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