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RSS FeedPosted by Michael Wonder on 09 Sep 2019
Inside drug makers' strategy to boost cancer medicines with 'Lazarus effect'
6 September 2019 - In the halls of MD Anderson Cancer Center, the drug Vitrakvi is known for having a “Lazarus ...
Posted by Michael Wonder on 09 Sep 2019
Novo Nordisk launching additional US insulin affordability offerings in January 2020
6 September 2019 - $99 Cash Card Program provides 3,000 - 3,600 units of any combination of Novo Nordisk analog insulins ...
Posted by Michael Wonder on 09 Sep 2019
FDA reiterates the importance of vaccines such as the Measles, Mumps, and Rubella (MMR) vaccine
6 September 2019 - The U.S. continues to experience cases and outbreaks of measles, largely due to unvaccinated or under-vaccinated segments ...
Posted by Michael Wonder on 09 Sep 2019
FDA grants AMG 510 fast track designation for previously treated metastatic NSCLC with KRAS G12C mutation
8 September 2019 - Amgen today announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with ...
Posted by Michael Wonder on 07 Sep 2019
Endo announces submission of biologics license application to FDA for collagenase clostridium histolyticum in patients with cellulite
6 September 2019 - Endo International announced today that the Company has submitted a biologics license application to the ...
Posted by Michael Wonder on 07 Sep 2019
FDA approves first treatment for patients with rare type of lung disease
6 September 2019 - The U.S. FDA today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary ...
Posted by Michael Wonder on 07 Sep 2019
Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114
6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, ...
Posted by Michael Wonder on 06 Sep 2019
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer
6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...
Posted by Michael Wonder on 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...
Posted by Michael Wonder on 05 Sep 2019
Is the FDA out to get this $2.9 billion diabetes drug class?
6 September 2019 - In March, the FDA issued a complete response letter -- the agency's euphemism for a rejection ...
Posted by Michael Wonder on 05 Sep 2019
GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease
5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...
Posted by Michael Wonder on 05 Sep 2019
Texas Doctor Stephen M. Hahn is a top contender to head FDA
4 September 2019 - M.D. Anderson’s radiation-oncology chief is among three leading candidates for post open since April. ...
Posted by Michael Wonder on 05 Sep 2019
Tricida announces submission of new drug application for veverimer for the treatment of metabolic acidosis in patients with chronic kidney disease
4 September 2019 - New drug application submitted under the FDA’s accelerated approval program. ...
Posted by Michael Wonder on 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...
Posted by Michael Wonder on 04 Sep 2019
Releasing the potential of real world evidence
4 September 2019 - Janssen believes RWE could realise an efficient, personalised and truly patient-centric health care system. ...