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EU Implementation Guide (IG) on veterinary medicines pr...

Apr 26, 2025 0

EU Implementation Guide (IG) on veterinary medicines product data in the Union P...

STAT+: Up and down the ladder: The latest comings and goings

STAT+: Up and down the ladder: The latest comings and g...

Apr 26, 2025 0

From new hires to departures, promotions and transfers, here are the latest comi...

Human medicines European public assessment report (EPAR): Wainzua, eplontersen, Date of authorisation: 06/03/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 26, 2025 0

Human medicines European public assessment report (EPAR): Wainzua, eplontersen, ...

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025

Meeting highlights from the Pharmacovigilance Risk Asse...

Apr 26, 2025 0

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad rang...

EU recommendations for 2025/2026 seasonal flu vaccine composition

EU recommendations for 2025/2026 seasonal flu vaccine c...

Apr 26, 2025 0

This news announcement was updated on 9 April 2025 to include a recommendation f...

Clinical Trials Information System designated as WHO primary registry

Clinical Trials Information System designated as WHO pr...

Apr 26, 2025 0

The Clinical Trials Information System (CTIS) has been designated as a primary r...

Streamlining development and assessment of biosimilar medicines

Streamlining development and assessment of biosimilar m...

Apr 26, 2025 0

EMA is exploring improvements to the development and evaluation of biosimilar me...

First report on EU-wide sales and use of antimicrobials in animals

First report on EU-wide sales and use of antimicrobials...

Apr 26, 2025 0

For the first time, all the 27 countries of the European Union (EU27) together w...

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025

Meeting highlights from the Committee for Medicinal Pro...

Apr 26, 2025 0

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP...

EMA business hours over Easter holiday period

EMA business hours over Easter holiday period

Apr 26, 2025 0

EMA's office is closed from 18:00 on Wednesday 16 April 2025 to 08:30 on Tuesday...

Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

Tackling vulnerabilities in the supply chain of radioph...

Apr 26, 2025 0

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Gr...

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025

Meeting highlights from the Committee for Veterinary Me...

Apr 26, 2025 0

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus...

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

FDA Approves First Rapid-Acting Insulin Biosimilar Prod...

Apr 26, 2025 0

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin...

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to...

Apr 26, 2025 0

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that ...

Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy

Tevimbra Approved in U.S. for First-line Treatment of A...

Apr 26, 2025 0

SAN MATEO, Calif.--(BUSINESS WIRE) Mar 04, 2025 -- BeiGene, Ltd. (NASDAQ: ONC; H...

FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults

FDA Approves TNKase (tenecteplase) for the Treatment of...

Apr 26, 2025 0

South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Gro...

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

FDA Approves Encelto (revakinagene taroretcel-lwey) for...

Apr 26, 2025 0

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private bi...

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients

ARS Pharmaceuticals Announces FDA Approval of neffy 1 m...

Apr 26, 2025 0

SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq:...

ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

ANI Pharmaceuticals Announces FDA Approval for Expansio...

Apr 26, 2025 0

BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (N...

FDA Approves Expanded Use of Soliris (eculizumab) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children

FDA Approves Expanded Use of Soliris (eculizumab) for P...

Apr 26, 2025 0

New York, March 10, 2025 – The Muscular Dystrophy Association (MDA) welcomes the...

FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥1)

FDA Approves Pembrolizumab for HER2 Positive Gastric or...

Apr 26, 2025 0

On March 19, 2025, the Food and Drug Administration granted traditional approval...

Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan), the First and Only Treatment Approved in C3 Glomerulopathy

Novartis Receives Third FDA Approval for Oral Fabhalta ...

Apr 26, 2025 0

Basel, March 20, 2025 – Novartis today announced that oral Fabhalta (iptacopan) ...

FDA Approves Tremfya (guselkumab) for Adult Patients with Moderately to Severely Active Crohn’s Disease

FDA Approves Tremfya (guselkumab) for Adult Patients wi...

Apr 26, 2025 0

HORSHAM, Pa. (March 20, 2025) – Johnson & Johnson (NYSE: JNJ) today announced th...

FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging

FDA Approves Gozellix (kit for the preparation of galli...

Apr 26, 2025 0

Melbourne Australia | 21 March 2025 -- Telix today announces that the United Sta...

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