US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777
Mumbai-based pharma and biotechnology company Wockhardt announced on Monday that its novel antibiotic WCK 6777 ...
Exclusive: Thermo Fisher's plant making infant RSV drug breached FDA rules, documents show
One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years ...
The American Journal of Managed Care2d
Nivolumab Approved as Neoadjuvant, Adjuvant Therapy for NSCLC by FDA
The approval came days before the FDA’s expected deadline and makes this the only PD-1 inhibitor approved for resectable ...
Head of CPD drug investigations is finalist for Iowa police chief job — and is saddled with mountain of debt
Joshua Wallace is seeking to become chief of the Des Moines Police Department. In February, he went bankrupt, reporting a ...
Monthly Prescribing Reference5d
FDA to Review Sepiapterin for Treatment of Phenylketonuria
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for sepiapterin as a treatment for pediatric and adult patients living with phenylketonuria (PKU).
BioSpace3d
Gilead Partners With Generics Developers to Provide HIV Drug to Low-Income Countries
Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for ...
Doctor who helped supply Matthew Perry ketamine pleads guilty to drug charge
LOS ANGELES (AP) — A San Diego doctor charged in connection with Matthew Perry ’s fatal overdose pleaded guilty Wednesday to ...
Morningstar6d
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
WARREN, N.J., Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of ...
Seeking Alpha5d
PTC Therapeutics brain disorder therapy granted FDA review
"The FDA filing acceptance for sepiapterin is a critical milestone toward bringing this potential important therapy to children and adults living with PKU in the United States," said PTC ...
Stockhouse6d
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
WARREN, N.J., Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of ...