FDA approved 1,171 generic drugs in 2019
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
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The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
Teva has agreed to supply opioid medication and make a cash payment in a settlement agreement that removes it from the Track 1 opioid litigation.
The International Society for Cell and Gene Therapy has created a group to tackle the rising number of commercial cell bank services that are misleading patients.
The Joint Pharmaceutical Analysis Group held an event in London, discussing the testing of nitrosamine mutagenic impurities in pharmaceutical products and the next steps for manufacturers to take.
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
The fight against antibiotic resistance could be improved with the discovery of a concept for fabricating nanomeshes as a drug delivery system.
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
A Phase II trial for an inhaled cystic fibrosis drug, intended for adults and adolescents, has enrolled its first patient.
A new report has said the osteoarthritis therapeutics market is estimated to grow due to rapid increase in the geriatric and obese population.
A new report has shown that from 2016/17 to 2018/19 clinical research has generated an estimated £8 billion of GVA for the UK.
The DHSC and three companies have signed contracts worth £25 million to ensure that essential medicines can be supplied to the UK in 24 to 48 hours.
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.