U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...

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Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis associated interstitial lung disease, a rare, debilitating condition

4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...

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Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma

3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...

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FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint

2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...

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FDA releases a new plan to bring its data skills up to speed

4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...

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FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma

4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...

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MedAlliance receives fourth FDA breakthrough device designation for sirolimus drug eluting balloon in treatment of de novo coronary lesions

4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...

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U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer

3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...

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Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA

2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...

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On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery

3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...

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Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA

3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...

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Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease

2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...

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KemPharm announces FDA approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once daily treatment for ADHD

2 March 2021 - KemPharm today announced that the U.S. FDA has approved the new drug application for Azstarys (formerly referred ...

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FDA grants de novo to ML-based, real-time indicator of patient deterioration

2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...

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Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine

2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...

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