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Drug Approvals

Psilocybin breakthrough therapy for major depression

The US FDA designated psilocybin, a compound found in hallucinogenic mushrooms, as a breakthrough therapy for the treatment of the Major Depressive Disorder (MDD) for the second year.

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Accelerated approval to Padcev for urothelial cancer

The US FDA granted accelerated approval to Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer, Astellas Pharma and Seattle Genetics announced.

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Enzalutamide to treat mCSPC

Pfizer and Astellas Pharma announced that the US FDA has approved a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

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FDA panel recommends olaparib for pancreatic cancer

AstraZeneca and MSD Inc said the US FDA Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend olaparib (Lynparza) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas, whose disease has not progressed following 1st-line platinum-based chemotherapy.

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Speedy approval to golodirsen for Duchenne

The US FDA granted accelerated approval to golodirsen (Vyondys 53) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping.

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Ivosidenib gets breakthrough therapy status for MDS

Ivosidenib (Tibsovo) has been granted breakthrough therapy status by USFDA for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation

Teprotumumab recommended for thyroid eye disease in US

Independent advisers to the US FDA voted unanimously in favour of teprotumumab, a perimental treatment for active thyroid eye disease, Horizon Therapeutics said.

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