Regulatory

Roche’s Xofluza approved by European Commission for children’s influenza treatment

The EC (European Commission) has approved Roche’s influenza treatment called Xofluxa, targeted toward children aged over a year. It can be used...

AstraZeneca receives FDA approval for its Asthma drug AirSupra

AstraZeneca has successfully received approval for its Asthma therapy- AirSupra. AstraZeneca (AZ) representative stated that the FDA has authorised...

Spectrum Labs Recalls Three Batches of Epinephrine Following Discoloration Complains

Spectrum Laboratory Products has voluntarily recalled all batches of epinephrine USP, a bulk API powder utilized in the production of the pharmaceutical...

FDA accelerated approval decision on Alzheimer’s drug likely to come soon

According to Biogen and Eisai, the accelerated approval decision for their Alzheimer’s drug could be made in early January by the FDA.

Ferring receives FDA approval for bladder cancer treatment after prior rejection

Ferring Pharmaceuticals has finally gotten FDA approval for its gene therapy medication Adstiladrin, a therapy used to treat bladder cancer patients. The...

FDA Pushes Back Lynparza Decision to March

The U.S. Food and Drug Administration (FDA) has postponed making a decision on Lynparza for metastatic castration-resistant prostate cancer (mCRPC), which is...

Cytokinetics Set to Make Its Case For Omecamtiv Mecarbil to FDA

Cytokinetics is set to present the benefits of omecamtiv mecarbil - its heart failure drug - to the FDA's advisory committee. However,...

Hemophilia gene therapy by CSL and uniQure is now the world’s most expensive medicine

The one-time gene therapy from uniQure and CSL Behring called Hemgenix or etranacogene dezaparvovec-drlb has been approved by the FDA, making it...

Latest news

FDA and CDC exploring unlikely relation between COVID-19 vaccine and stroke

The FDA and CDC have brought out new revelations that the revised COVID-19 injection from Pfizer Inc...

Disappointing sales prompt AstraZeneca to pull out leukemia drug Lumoxiti from U.S. market

In a letter shared with healthcare providers, AstraZeneca has announced that it will be pulling its leukemia...

Sanofi’s Venture Capital units to receive over $750 million in investment to boost firm’s investment capabilities 

After a successful last year in which Sanofi Ventures made its second-highest number of deals, 10 rounds...

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Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

Amgen’s KRAS drug gets early FDA approval for lung cancer with specific mutation

On Friday, the United States FDA (Food and Drug Administration) has authorized a medication of Amgen Biopharmaceutical in patients with NSCLC

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Concerns Grow Over Safety of BioGen’s Aduhelm after Death of More Patient Who Got the Drug

Biogen began investigations in November 2021 into the untimely demise of a 75-year-old woman from a neurological problem.

Janssen files for Covid19 vaccine approval in Japan

Janssen pharmaceuticals K.K., a department of Johnson& Johnson pharmaceuticals, has announced on Monday that it has applied to the Health Ministry of Japan to approve its Covid-19 vaccine.