US FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
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2024 Novel Drug and Biological Product Approvals
The FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.
Could New Government Changes Affect the Safety of Your Beauty Products?
FDA regulation of cosmetics and beauty products may change under the new administration. Here's what you need to know if that ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
Hims & Hers Super Bowl ad slams pricey pharma industry—and fumbles FDA warnings on compounded GLP-1 drugs
Taking a compounded GLP-1 medication isn’t the same thing as your pharmacy filling a cheaper, generic version of the drug ...
Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease
ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s diseaseONAPGO is a wearable subcutaneous infusion ...
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FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
The U.S. Food and Drug Administration (FDA) approved suzetrigine under the brand name Journavx on Jan. 30, 2025. Journavx is a first-in-class non-opioid painkiller that acts on sodium channels in the ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
Rockville's OS Therapies acquires rights to key drugs, eyes FDA approval for cancer therapy
A Rockville immunotherapy company struck an $8 million deal to take back ownership of the drug candidates it’s been licensing ...
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Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...