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Regulatory Intelligence & Drug Approvals1 month agoFDA/Center for Research on Complex Generics (CRCG) Workshop on Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment – 12/01/2026
This 2-day hybrid workshop brings together FDA, industry, and academic experts to address the most pressing scientific and regulatory challenges of long-acting injectable (LAI) generic drug...
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Regulatory Intelligence & Drug Approvals1 month agoSupporting Clinical Practice Guidelines for Drugs with Abuse Potential
Information regarding the FDA's efforts to support the development of clinical practice guidelines for drugs with abuse potential.
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Regulatory Intelligence & Drug Approvals1 month agoBentley Laboratories LLC – 732028 – 09/17/2026
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
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Regulatory Intelligence & Drug Approvals1 month agoCelmade – 735876 – 09/14/2026
Review of Website/Unapproved New Drug/Misbranded
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Regulatory Intelligence & Drug Approvals1 month agoAstraZeneca to invest $2bn in Summit for ADC combination therapies
Under the transaction, AstraZeneca will acquire around 109,000 preferred shares convertible into Summit common stock at a 1:1,000 ratio. This will provide an estimated 12% stake...
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Regulatory Intelligence & Drug Approvals1 month agoFDA clears first drug for MCT8 deficiency
Sweden's Egetis has won approval in the US for the first-ever treatment for people living with the ultra-rare genetic disease MCT8 deficiency.
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Emcitate (tiratricol) for the Treatment of Patients with MCT8 Deficiency
STOCKHOLM, SWEDEN, Sept. 28 2026. (GLOBE NEWSWIRE) – Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (Nasdaq Stockholm: EGTX) today announced that the U.S. Food and...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Degevma (denosumab-adet), a Biosimilar to Xgeva
TEL AVIV, Israel, and PARSIPPANY, N.J., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food...
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration today approved Emcitate (tiratricol) tablets for oral suspension to treat peripheral thyrotoxicosis (excess thyroid hormone levels in the blood that...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Juvmo (tavapadon) for the Treatment of Parkinson’s Disease
NORTH CHICAGO, Ill., Sept. 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Juvmo (tavapadon) tablets...
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
