U.S. 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 ...
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 ...
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 ...
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End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
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 ...
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 ...
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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FDA Approves GRAFAPEX/Fludarabine Before alloHSCT in AML and MDS
The FDA has approved GRAFAPEX™ and fludarabine as a preparative regimen in acute myeloid leukemia or myelodysplastic syndrome ...
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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 ...