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Many Cancer Drugs Still Unproven 5 Years After Accelerated Approval

New research questions the effectiveness of the FDA's accelerated drug approval program after finding that most cancer drugs remain unproven five years later.

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FDA Clears Sickle Cell Drug to Treat Another Blood Disorder

Casgevy, a groundbreaking treatment approved to treat sickle cell disease in December, has now been approved to treat another inherited blood disorder.

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FDA Asked to Consider Party Drug MDMA as Treatment for PTSD

A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD).

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FDA Approves First Vaccine for Chikungunya Virus

the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.

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New Postpartum Depression Drug Comes With Hefty Price Tag

A newly approved medication to treat postpartum depression will cost $15,900 per 14-day course, before insurance, when it reaches the market later this year, raising concerns among doctors and researchers that some patients may have trouble paying for the drug.

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FDA Approves Bosutinib for Pediatric Patients With CP-CML

Bosutinib has a new indication in leukemia as a well as a newly-approved formulation.

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FDA Calendar, FDA Drug Approval, PDUFA Dates – RTTNews

FDA calendar is a useful tool to know PDUFA dates related to FDA Approval and FDA Panel review of New Drug Applications, which are catalysts of Biotech Stocks.

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Surprise! Amgen's hot KRAS drug seals early FDA approval, winning a shot against 'undruggable' cancer

What was once considered the "Achilles heel" of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company's KRAS inhibitor, Lumakras.

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Roche's arthritis drug Actemra scores FDA nod in rare autoimmune disease after partial clinical win

Mar 5, 2021 11:20am
Roche's Actemra has become the first biologic that the FDA approved for patients with systemic sclerosis-associated interstitial lung disease. (Roche/Genentech)
Missed the primary endpoint of a clinical trial? No problem. We’ll pick the study apart and approve your drug based on a post-hoc subgroup analysis.
That’s what the FDA did in granting Roche’s Actemra a go-ahead in patients with interstitial lung disease (ILD) associated with the rare autoimmune disease systemic sclerosis (SSc).
The approval makes Actemra the first biologic drug cleared by the FDA to slow the decline in pulmonary function in patients with SSc-ILD, Roche’s Genentech said Thursday.

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Why did India approve Covaxin, Covishield, not Pfizer, Sputnik V? — Quartz India

This will be a policy hurdle that Johnson & Johnson’s pharmaceutical company, Janssen, will also need to clear for its single-dose vaccine.

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