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7032 News Found

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Drug Approval | July 04, 2023

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)


Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24
Drug Approval | July 03, 2023

Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24

Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.


Annovis’ Buntanetap in PD faces complex road ahead despite phase III progress, says GlobalData
News | July 03, 2023

Annovis’ Buntanetap in PD faces complex road ahead despite phase III progress, says GlobalData

The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023


Merck to expand reagent production capacity in China
News | June 30, 2023

Merck to expand reagent production capacity in China

The €70 million investment will allow the large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers, increasing annual output by several thousand tons


Shilpa Medicare launches Lenvatinib Capsules in India under the brand name Lenshil
News | June 30, 2023

Shilpa Medicare launches Lenvatinib Capsules in India under the brand name Lenshil

The company is already marketing the 4 mg and 10 mg strengths


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands


USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata
Drug Approval | June 27, 2023

USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata

LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12


Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars
News | June 26, 2023

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA


Eugia Pharma signs voluntary license with Medicines Patent Pool to develop generic version of Nilotinib Capsules
News | June 24, 2023

Eugia Pharma signs voluntary license with Medicines Patent Pool to develop generic version of Nilotinib Capsules

The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India