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FDA greenlights GW's Epidiolex, the first U.S. drug made from marijuana fiercepharma
June 26, 2018
The FDA just approved Epidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment...
10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid fiercevaccines
June 26, 2018
How long is a drugmaker willing to wait on an indication expansion plan? For Merck’s HPV vaccines, that's 10 years.
Drug shortages again on the rise after 5 years of improvements, FDA says fiercepharma
June 25, 2018
After 5 years of declines in the number of new drug shortages in the U.S., they jumped to 39 last year from 26 in the two preceding years.
Medivir delays pivotal HDAC trial as FDA discussions stall fiercebiotech
June 25, 2018
A year ago, Medivir was riding high after reporting midstage data that encouraged it to press ahead with a pivotal trial of its HDAC inhibitor remetinostat in cutaneous T-cell lymphoma (CTCL).
FDA hits Ziopharm CAR-T trial with clinical hold fiercebiotech
June 25, 2018
Until recently, Ziopharm’s top priority was to get inducible adenoviral vector Ad-RTS-hIL-12 into a pivotal brain cancer trial.
FDA places hold on Ziopharm CAR-T trial pharmafile
June 22, 2018
CAR-T is emerging as one of the most potentially exciting therapies in the industry, particularly as a beacon for the collective push towards personalised treatment, so it is unsurprising that many small biotechs are currently pursuing treatments within t
FDA rejects Valeant plaque psoriasis lotion over pharmacokinetic concerns pharmafile
June 22, 2018
Beleaguered pharma firm Valeant has come up against another bump in the road as its plaque psoriasis lotion Duobrii (halobetasol propionate and tazarotene) was rejected for US approval by the FDA.
FDA and EMA accept marketing application for Pfizer’s talazoparib pharmaceutical-technology
June 13, 2018
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Pfizer’s marketing authorisation application for its talazoparib drug to treat metastatic breast cancer patients with an inherited BRCA mutation.
FDA beefs up generics-use push with radio PSAs fiercepharma
June 13, 2018
The FDA campaign to promote wider use of generics got a bigger media push recently with the addition of radio.
AcelRx Announces FDA Acceptance of NDA for DSUVIA drugs
June 12, 2018
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings

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