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1549 News Found

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
News | May 15, 2023

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations


USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause
Drug Approval | May 13, 2023

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause


USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Drug Approval | May 12, 2023

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time


Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007
Drug Approval | May 08, 2023

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery


Wacker acquires Spain-based biotech firm ADL BioPharma
News | May 08, 2023

Wacker acquires Spain-based biotech firm ADL BioPharma

The acquisition of ADL BioPharma now makes WACKER owner of the entire plant, with total fermentation capacities of just under 3,000 cubic meters


Briefs: Dr. Reddy's Laboratories
News | May 06, 2023

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation


Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.