Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab

17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...

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Eagle Pharmaceuticals submits response to complete response letter from FDA for vasopressin

17 June 2021 - Eagle Pharmaceuticals today announced that it has responded to the complete response letter for its abbreviated ...

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Braeburn resubmits new drug application for Brixadi (buprenorphine) extended release subcutaneous injection for moderate to severe opioid use disorder

15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous ...

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Emmaus Life Sciences announces submission of marketing authorisation application to Swissmedic; Ideogen to manage early access program

15 June 2021 - Emmaus Life Sciences anounced today it has received confirmation from the Swiss Agency for Therapeutic Products ...

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Hugel America announces U.S. FDA acceptance of biologics license application for letibotulinumtoxinA for injection to treat glabellar (frown) lines

15 June 2021 - Prescription Drug User Fee Act target action date of 31 March 2022. ...

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Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada

14 June 2021 - Submission supported by data from the CENTAUR trial. ...

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Moderna seeks vaccine approval for adolescents

11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...

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Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency

11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...

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Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis

11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...

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Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?

10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...

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FDA accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose

10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...

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Adamis provides update on Zimhi

9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...

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BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in microsatellite instability-high or mismatch repair-deficient solid tumours

7 June 2021 -BeiGene today announced that the Center for Drug Evaluation of the China NMPA has accepted a supplemental ...

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Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease

8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...

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Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents

7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...

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