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FDA Drug Information UpdatesEpisodes
Episodes of FDA Drug Information Updates
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The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to transform raw data into usable information. One of these tools is called the FDA Adverse Event
The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to transform raw data into usable information. One of these tools is called the FDA Adve
The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune sy
The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This
Oncologists Dr. Sanjeeve Bala and Dr. Abhilasha Nair from FDA’s Oncology Center of Excellence discuss the recent approval of bevacizumab-awwb, a biosimilar to US-licensed Avastin, marketed as MVASI. MVASI is the first biosimilar appro
Oncologists Dr. Sanjeeve Bala and Dr. Abhilasha Nair from FDA’s Oncology Center of Excellence discuss the recent approval of bevacizumab-awwb, a biosimilar to US-licensed Avastin, marketed as MVASI. MVASI is the first biosimilar approved in the
The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, including the bra
The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, includi
The FDA announced that a review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious ast
The FDA announced that a review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-relate
Guest: Leonard H. Calabrese, DO Guest: John R. Tesser, MD This activity provides patient and practice-specific biosimilars content for clinicians in rheumatology practice.
Guest: Leonard H. Calabrese, DO Guest: John R. Tesser, MD This activity provides patient and practice-specific biosimilars content for clinicians in rheumatology practice.
Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's O
Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of S
FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease. Released August 17, 2017
FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease. Released August 17, 2017
FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Released July 28, 2017
FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Released July 28, 2017
FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Released July 25, 2017
FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Released July 25, 2017
The D.I.S.C.O. hosts discuss the agency’s first approval of pembrolizumab, a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Released May 30, 2017.
The D.I.S.C.O. hosts discuss the agency’s first approval of pembrolizumab, a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Released May 30, 2017.
FDA medical oncologists discuss the agency’s March 23, 2017 approval of avelumab for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. Released May 22, 2017
FDA medical oncologists discuss the agency’s March 23, 2017 approval of avelumab for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. Released May 22, 2017
FDA medical oncologists discuss the agency’s March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial res
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