Topic: complete response letter
GSK's ViiV said the CRL is related to chemistry manufacturing and controls, not the drug's safety profile.
Hoping to revive the case, AstraZeneca said it will submit results from another phase 3 trial that weren't originally included in its application.
Biotech Acacia has its third PDUFA date for its drug candidate for post-operative nausea after manufacturing related CRLs twice sidelined it.
Biocon's manufacturing problems cost it and Mylan again; CStone's CEO racks up nearly $20 million in 2018 pay; Novartis sells Suzhou plant.
An FDA Form 483 outlined a host of failings at Dr. Reddy's oncology plant in India, a facility hat has repeatedly had quality problems.
The FDA issued a CRL to Mylan for its Lantus copy because of issues it found at the Biocon site where the partners manufacture the insulin drug.
Sun's Shanghvi took a 99% pay cut last year. Dr. Reddy's copies of Copaxone and NuvaRing were rejected by the FDA. Natco eyes China amid hardship.
Dr. Reddy’s, which has been dealing with manufacturing setbacks, has received a complete response letter for two potentially lucrative products.
Biohaven Pharmaceuticals has been unexpectedly hit by a complete response letter for using an Apotex API.
Turns out, the FDA’s March rejection of Sanofi's Zynquista was just a preview of what would come for the SGLT class in Type 1 diabetes.