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Results For "USFDA"

1355 News Found

Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India
News | November 17, 2023

Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India

Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain


Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).


FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents
Drug Approval | October 21, 2023

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease


Glenmark receives ANDA approval for Apremilast Tablets
Drug Approval | October 18, 2023

Glenmark receives ANDA approval for Apremilast Tablets

Glenmark's current portfolio consists of 188 products authorized for distribution in the US


Lupin enters into BTA with Lupin Manufacturing Solutions
News | October 17, 2023

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Briefs: Mankind Pharma and Sequent Scientific
News | September 26, 2023

Briefs: Mankind Pharma and Sequent Scientific

Mankind Pharma commences the commercial operations newly set-up plant in Udaipur


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia
Drug Approval | September 19, 2023

Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia

Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy