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Category: FDA


FDA, Regulations

FDA clears Keytruda for first-line cervical cancer

October 14, 2021

Via: Pharma Times

The FDA has cleared Keytruda in combination with chemotherapy – with or without bevacizumab – for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1. In the Phase III KEYNOTE-826 trial in this patient population, Keytruda plus […]


FDA, Regulations

FDA Approves ChemoCentryx’s Tavenos

October 8, 2021

Via: Biopharm International

ChemoCentryx, a biopharmaceutical company targeting the chemokine and chemoattractant systems, announced that FDA approved Tavenos (avacopan), an orally-administered selective complement 5a receptor inhibitor, on Oct. 8th, 2021. Avacopan was approved as an adjunctive treatment for adults with severe active anti-neutrophil […]


FDA, Regulations

New FDA draft guidance on microbiological quality of NSDs

October 6, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released new draft guidance surrounding on ‘Microbiological Quality Considerations in Non-Sterile Drug Manufacturing’. The draft will be available for public comment for up to 90 days after 30 September 2021. The guidance […]


FDA, Regulations

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

October 1, 2021

Via: Biopharm International

Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into the research and approval processes, notably data provided by patient registries and medical records able to inform traditional clinical […]


FDA, Regulations

FDA Approves AbbVie’s Qulipta

September 30, 2021

Via: Biopharm International

AbbVie announced that FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraines in adults on Sept. 28, 2021. According to a company press release, Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) […]


FDA, Regulations

Eisai, Biogen to test FDA by asking for approval of second Alzheimer’s drug

September 28, 2021

Via: Biopharma Dive

The Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm in early June has become one of the most controversial and publicly acrimonious decisions in the agency’s recent history. In the nearly four months since, the decision has led […]


FDA, Regulations

FDA’s ongoing review of accelerated cancer approvals targets 2 drugs from Secura and Aurobindo

September 24, 2021

Via: FiercePharma

The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there. The FDA is gathering an oncologic drugs advisory committee meeting on Dec. […]


FDA, Regulations

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

September 23, 2021

Via: Biopharm International

FDA granted accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, according to a Sept. 20, 2021, FDA press release. According to the Seagen company press release, Tivdak is the first and […]


FDA, Regulations

FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans

September 22, 2021

Via: Biopharma Dive

The Food and Drug Administration will allow older adults and people at high risk of severe COVID-19 to receive a third dose of Pfizer and BioNTech’s coronavirus vaccine, announcing Wednesday night an amended emergency authorization for the shot. The regulator’s […]


FDA, Regulations

FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer

September 21, 2021

Via: Pharma Times

DTC is usually treated with surgery, followed by the removal of the remaining thyroid tissues with radioiodine. However, approximately 5% to 15% of cases are resistant to radioiodine treatment, with these patients carrying a life expectancy of only three to […]


FDA, Regulations

FDA Advisory Panel to Meet on COVID Booster Shots

September 17, 2021

Via: Drugs.com

U.S. Food and Drug Administration advisors will meet Friday to consider whether it is safe and effective for Americans to receive a third “booster” dose of the Pfizer-BioNTech COVID-19 vaccine. The FDA posted the materials it intends to use in […]


FDA, Regulations

Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC

September 16, 2021

Via: European Pharmaceutical Review

Takeda have announced that the US Food and Drug Administration (FDA) has approved Exkivity™ (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion […]