Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

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Updates on Olumiant (baricitinib) FDA review for atopic dermatitis

28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...

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Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer

28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...

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Highlights from CHMP 24-27 January meeting

28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...

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Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...

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Moderna aims to deliver Omicron COVID-19 vaccine by September

27 January 2022 - A COVID-19 booster shot, targeted specifically at the Omicron variant, is expected to be delivered by ...

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FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty

27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...

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FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion

27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...

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TGA approves Tepmetko for patients with non-small-cell lung cancer

27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...

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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour

24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...

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COVID-19 vaccine weekly safety report (27 January 2022)

27 January 2022 - To 23 January 2022, the TGA has received 431 reports which have been assessed as likely to ...

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Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA

27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...

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Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...

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Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency

25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...

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