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In April 2021, the FDA approved the 100th monoclonal antibody as a therapeutic entity, a milestone that took 35 years to reach. As of the fall of 2022, the FDA has approved 162 antibody

We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system

PPF Group, an international investment group, today announced the signing of a binding agreement to sell its stake in NBE-Therapeutics to Boehringer Ingelheim. NBE-Therapeutics is using its proprietary iADC™ platform to develop potential best-in-class antibody-drug conjugate (ADC) therapies for the treatment of solid tumors.

Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube and pump formats.

Pharma giant Boehringer Ingelheim strengthened its immuno-oncology portfolio this week by inking an acquisition deal with NBE Therapeutics for a tidy $1.4 billion US.

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

NBE-Therapeutics AG, a biopharmaceutical company developing best-in-class, immune-stimulatory antibody drug conjugates (iADCs™), announces the appointment of Dr. Steffen Heeger as Chief Medical Officer (CMO).

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.