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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Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia

3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...

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New legislation to support medicine substitutions

5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...

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TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant

5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...

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Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis

3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...

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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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EMA starts rolling review of the Sputnik V COVID-19 vaccine

4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...

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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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