FDA will drop two-study requirement for new drug approvals, aiming to speed access
For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients ...
Tag: drug
Trump Pressures FDA on Vaccines; Obesity Drug May Shed Too Much; Texas Hospital Sued
(MedPage Today) -- Note that some links may require registration or subscription. President Trump told FDA Commissioner Marty Makary, MD, ...
Novel Rapid-Acting Drug Proves Effective in Severe PTSD
(MedPage Today) -- The investigational neuroplastogen TSND-201 showed significant efficacy in patients with severe post-traumatic stress disorder (PTSD), according to ...
AstraZeneca gets regulator’s nod to market cancer drug Imfinzi for additional indication
The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 120 mg/2.4 mL and 500 ...
Antimicrobial resistance: Charles Darwin was right; India’s drug policy isn’t
Antibiotics aren’t only pharmacological agents: they are evolutionary interventions that reshape microbial populations wherever they are deployed Source: www.thehindu.com Medical ...
Zydus gets orphan drug status for Sickle Cell Disease medication
Therapeutic options for management of Sickle Cell Disease are currently limited Source: www.thehindu.com Medical Disclaimer: This content is shared for ...
Autism Trial Supporting FDA-Touted Drug Is Retracted
(MedPage Today) -- One of the largest autism trials of leucovorin (Wellcovorin), a drug used to treat cerebral folate deficiency, ...
India must scale up non-animal methods for pre-clinical drug testing, say experts
India must scale up non-animal methods for pre-clinical drug testing, say experts Source: www.thehindu.com Medical Disclaimer: This content is shared ...
FDA Wants Drug Pulled From Market, Citing Liver Risk. Company Says No.
(MedPage Today) -- The FDA has requested that Amgen voluntarily withdraw avacopan (Tavneos), a treatment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated ...
The story of dapsone: from dye to drug
For much of human history, there was no reliable method to treat leprosy. The discovery that a chemical compound used ...