Biopharma

Pliant pauses phase 2 lung fibrosis trial on advice of ...

Pliant Therapeutics has hit the breaks on a mid-stage trial of its lead liver di...

Medical devices

Medical devices

Advice to medical device manufacturers - 2025 Timetable

Advice to medical device manufacturers - 2025 Timetable

Request for advice on the clinical development strategy...

Request for advice on the clinical development strategy and / or clinical invest...

Guide to manufacturers on the procedure for requesting ...

Guide to manufacturers on the procedure for requesting advice from expert panels...

EMA establishes regular procedure for scientific advice...

EMA, in close collaboration with the European Commission, has established a stan...

Linguistic review - Human

Linguistic review - Human

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Bridion, sugammadex, D...

The role of diagnostics in advancing antibody-drug conj...

Antibody-drug conjugates (ADCs) are revolutionizing oncology, but success requir...

Opinion: STAT+: The life sciences industry needs a new ...

The life sciences industry must step up to reduce the gap between health care sp...

Opinion: The FDA’s misguided thinking on antibiotics

The public misunderstands antibiotic-resistant infections — and so does the FDA.

STAT+: Two biotechs say they’re using AI to conjure dru...

A STAT examination shows how AI-powered biotechs like Absci and Generate Biomedi...

STAT+: Amid shakeup in U.S. science, researchers expres...

Amid a shakeup in U.S. science, researchers are expressing alarm over the integr...

U.S. FDA Grants Orphan Drug Designation to Ariceum Ther...

Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a private bio...

STAT+: Here’s how big a hit some universities may take ...

Documents analyzed by STAT show that big losers under the NIH's cuts to biomedic...

STAT+: Researchers ‘stunned’ after HHMI abruptly cancel...

The Howard Hughes Medical Institute abruptly ended a $60 million program to impr...

FDA Approves Emblaveo (aztreonam and avibactam) for the...

NORTH CHICAGO, Ill., Feb. 7, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today anno...

FDA Approves Emblaveo (aztreonam and avibactam) for the...

NORTH CHICAGO, Ill., Feb. 7, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today anno...

FDA Alerts Patients of Potential to Miss Critical Safet...

The FDA is alerting patients of a safety concern regarding diabetes devices that...

Eledon Pharmaceuticals Announces Use of Tegoprubart as ...

IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (...

Salarius Pharmaceuticals Announces Patient Enrollment t...

HOUSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasda...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Izelvay, avacincaptad ...

Availability of medicines before and during crises

Availability of medicines before and during crises

Non-clinical Working Party

Non-clinical Working Party

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