The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.
The US Food and Drug Administration (FDA) has released a new final guidance document regarding how manufacturers of pharmaceutical products can make changes to their manufacturing equipment under ...
Morning Overview on MSN
The FDA just added a kidney-damage warning to a popular over-the-counter diet pill
Anyone who has picked up a box of alli from a drugstore shelf without a prescription now faces a new risk disclosure. The FDA ...
Morning Overview on MSN
The FDA approved a new drug for thyroid eye disease, a condition that pushes the eyes forward
Patients with thyroid eye disease, a condition that causes the eyes to bulge forward due to swelling behind the eyeball, now ...
GlobalData on MSN
FDA changes rare disease tune again as it clears path for Regenxbio’s gene therapy
With a regulatory route now in place, Regenxbio expects to meet with the FDA again in July, with a BLA resubmission to follow in Q3 2026.
The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection ...
Replimune Group, Inc. nears a pivotal FDA AdCom for RP1 ahead of an Aug 2, 2026 decision. Click for this REPLY stock update ...
MedPage Today on MSN
NEJM Retracts Pivotal Trial of FDA-Approved Drug
Move follows actions "inconsistent with proper research conduct," journal says ...
Pharmaceutical Technology on MSN
FDA oncology roundup: drugs, imaging agents and diagnostics gain approval
The FDA has cleared several oncology products over the past few days, ranging from therapies to diagnostic and imaging tools.
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