Biopharma

Data in regulation: Big data and other sources

Data in regulation: Big data and other sources

Medical record fallout from Trump’s executive orders

In this edition of STAT Health Tech: How an executive order on gender identity i...

Prosecutors directed to seek death penalty against Unit...

U.S. Attorney General Pam Bondi said Tuesday she has directed federal prosecutor...

Judge overturns FDA’s lab developed test regulation, si...

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the la...

DC court backs HHS in rejecting Vertex's proposed ferti...

A District Court backed the U.S. government in its ruling that Vertex's fertilit...

HHS begins layoffs in chaotic fashion

Reduction-in-force notices went out Tuesday morning to employees across HHS. At ...

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...

After dismissal of 3rd bankruptcy settlement, Johnson &...

With the decision of a Texas federal judge to dismiss Johnson & Johnson's third ...

IRIS guide to registration and RPIs

IRIS guide to registration and RPIs

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Bortezomib Accord, bor...

EMEA-003523-PIP01-23

EMEA-003523-PIP01-23

Pharma majors put lobbyists to work to stagger tariff r...

As President Donald Trump threatens to impose sweeping geographic tariffs this w...

EMEA-003515-PIP01-23

EMEA-003515-PIP01-23

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Slenyto, melatonin, Da...

After Eric Green's exit, new leader of NIH's genome res...

Vence Bonham Jr., the highest ranking official at the National Human Genome Rese...

Trump administration sued over decision to rescind bill...

A coalition of state attorneys general sued the Trump administration on Tuesday ...

EMEA-003299-PIP02-22

EMEA-003299-PIP02-22

EMEA-003522-PIP01-23

EMEA-003522-PIP01-23

After Eric Green’s exit, new leader of NIH’s genome res...

Vence Bonham Jr., the highest ranking official at the National Human Genome Rese...

Biopharmas laid off staffers at least 63 times in Q1: F...

At least 63 biopharma layoff rounds were conducted in the first quarter of this ...

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

Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab,...

Fierce Biotech Fundraising Tracker '25: AIRNA nets $155...

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

Switzerland's SHL Medical debuts $220M autoinjector pla...

Drug delivery specialist SHL Medical opened the doors to its new $220 million au...

Cerevance fails phase 2 trial in early, untreated Parki...

Cerevance’s attempt to unlock the first-line Parkinson's disease market has hit ...

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