Biopharma

European Medicines Agency’s data protection notice rega...

Feb 18, 2025 0

European Medicines Agency’s data protection notice regarding personal data proce...

Maximum residue limits (MRL)

Maximum residue limits (MRL)

Feb 18, 2025 0

Maximum residue limits (MRL)

EMEA-003155-PIP01-21-M01

EMEA-003155-PIP01-21-M01

Feb 18, 2025 0

EMEA-003155-PIP01-21-M01

EMA Open Door Day, European Medicines Agency, Amsterdam, the Netherlands, from 9 May 2025, 09:45 (CEST) to 9 May 2025, 16:00 (CEST)

EMA Open Door Day, European Medicines Agency, Amsterdam...

Feb 18, 2025 0

EMA Open Door Day, European Medicines Agency, Amsterdam, the Netherlands, from 9...

Human medicines European public assessment report (EPAR): Azacitidine Accord, azacitidine, Date of authorisation: 13/02/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 18, 2025 0

Human medicines European public assessment report (EPAR): Azacitidine Accord, az...

ACT EU workshop on ICH E6 R3 (principles and Annex 1) , Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 19 February 2025, 09:30 (CET) to 20 February 2025, 14:00 (CET)

ACT EU workshop on ICH E6 R3 (principles and Annex 1) ,...

Feb 18, 2025 0

ACT EU workshop on ICH E6 R3 (principles and Annex 1) , Online, European Medicin...

Programme - EMA's Open Door Day

Feb 18, 2025 0

Programme - EMA's Open Door Day

Agenda - ACT EU workshop on ICH E6 (R3)

Feb 18, 2025 0

Agenda - ACT EU workshop on ICH E6 (R3)

FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog

FDA Approves Merilog (insulin-aspart-szjj), a Biosimila...

Feb 18, 2025 0

February 14, 2025 -- Today, the U.S. Food and Drug Administration approved Meril...

STAT+: STAT is backing up and monitoring CDC data in real time: See what’s changing

STAT+: STAT is backing up and monitoring CDC data in re...

Feb 17, 2025 0

STAT is backing up and monitoring CDC data in real time: See what's changing.

FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva

FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva

Feb 17, 2025 0

INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that t...

STAT+: Drug inspectors, AI experts, maternal health workers: Trump’s health agency cuts are far-reaching

STAT+: Drug inspectors, AI experts, maternal health wor...

Feb 17, 2025 0

"Read this email immediately” That was the subject line of emails that landed in...

Lundbeck’s Potential Treatment Amlenetug for Multiple System Atrophy Receives Fast Track Designation From the FDA

Lundbeck’s Potential Treatment Amlenetug for Multiple S...

Feb 17, 2025 0

Wed, Feb 12, 2025 -- The FDA has granted Fast Track Designation to Lundbeck’s in...

At premier science gathering, ‘anger, uncertainty, and anxiety’ about the future of research under Trump

At premier science gathering, ‘anger, uncertainty, and ...

Feb 17, 2025 0

At the AAAS annual meeting, "anger, uncertainty, and anxiety" about the future o...

STAT+: CDC cuts expected to devastate Epidemic Intelligence Service, a ‘crown jewel’ of public health

STAT+: CDC cuts expected to devastate Epidemic Intellig...

Feb 17, 2025 0

Members of the CDC's Epidemic Intelligence Service were warned Friday that many ...

FDA Grants Fast Track Designation to PleoPharma, Inc's Investigational New Drug, PP-01, for the Mitigation of Cannabis Withdrawal Symptoms in Patients With Cannabis Use Disorder

FDA Grants Fast Track Designation to PleoPharma, Inc's ...

Feb 17, 2025 0

PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately h...

$Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome$

Innate Pharma Announces U.S. FDA Granted Breakthrough T...

Feb 17, 2025 0

February 17, 2025 -- Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Inna...

STAT+: Trump administration to fire thousands at health agencies

STAT+: Trump administration to fire thousands at health...

Feb 17, 2025 0

The Trump administration is set to eliminate thousands of federal health care jo...

STAT+: The view from overseas on tumult in U.S. science

STAT+: The view from overseas on tumult in U.S. science

Feb 17, 2025 0

And other biotech news stories from the day.

Template for assessment report for the development of European Union herbal monographs and list entries

Template for assessment report for the development of E...

Feb 17, 2025 0

Template for assessment report for the development of European Union herbal mono...

Template for a European Union herbal monograph

Template for a European Union herbal monograph

Feb 17, 2025 0

Template for a European Union herbal monograph

Agenda of the COMP meeting 18-19 February 2025

Feb 17, 2025 0

Agenda of the COMP meeting 18-19 February 2025

Interested Parties to the HMPC

Interested Parties to the HMPC

Feb 17, 2025 0

Interested Parties to the HMPC

Human medicines European public assessment report (EPAR): Cibinqo, abrocitinib, Date of authorisation: 09/12/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Cibinqo, abrocitinib, ...

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